STJ ST. Jude Medical, Inc.

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INDEX TO CONSOLIDATED FINANCIAL STATEMENTS AGA MEDICAL HOLDINGS, INC.

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As filed with the Securities and Exchange Commission on November 15, 2010

Registration No. 333-170045

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Amendment No. 2
to
FORM S-4
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

ST. JUDE MEDICAL, INC.
(Exact Name of Registrant as Specified in Its Charter)

One St. Jude Medical Drive
St. Paul, Minnesota 55117
(651) 756-2000
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant's Principal Executive Offices)

Pamela S. Krop
Vice President, General Counsel and Secretary
St. Jude Medical, Inc.
One St. Jude Medical Drive
St. Paul, Minnesota 55117
(651) 765-2000
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent For Service)

           Approximate date of commencement of proposed sale to the public: As soon as practicable after the effectiveness of this registration statement and upon consummation of the transactions described in the enclosed prospectus/offer to exchange.

          If any of the securities being registered on this form are to be offered in connection with the formation of a holding company and there is compliance with General Instruction G, check the following box.  o

          If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  o                

          If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  o                

          Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.

If applicable, place an X in the box to designate the appropriate rule provision relied upon in conducting this transaction:

Exchange Act Rule 13e-4(i) (Cross-Border Issuer Tender Offer) o
Exchange Act Rule 14d-1(d) (Cross Border Third-Party Tender Offer) o

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           The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

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THE INFORMATION IN THIS PROSPECTUS/OFFER TO EXCHANGE MAY CHANGE. ST. JUDE MEDICAL, INC. MAY NOT COMPLETE THIS EXCHANGE OFFER AND ISSUE THESE SECURITIES UNTIL THE REGISTRATION STATEMENT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS PROSPECTUS/OFFER TO EXCHANGE IS NOT AN OFFER TO SELL THESE SECURITIES AND ST. JUDE MEDICAL, INC. IS NOT SOLICITING AN OFFER TO BUY THESE SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.

PRELIMINARY PROSPECTUS/OFFER TO EXCHANGE

ST. JUDE MEDICAL, INC.
OFFER TO EXCHANGE EACH OUTSTANDING SHARE OF COMMON STOCK
OF
AGA MEDICAL HOLDINGS,  INC.
FOR
$20.80 IN CASH
OR
$20.80 IN FAIR MARKET VALUE OF ST. JUDE MEDICAL, INC. COMMON STOCK
SUBJECT IN EACH CASE TO ADJUSTMENT AND PRORATION AS DESCRIBED IN THE PROSPECTUS/OFFER TO EXCHANGE AND THE RELATED LETTER OF ELECTION AND TRANSMITTAL

           THE EXCHANGE OFFER AND WITHDRAWAL RIGHTS WILL EXPIRE AT 12:00 MIDNIGHT (ONE MINUTE AFTER 11:59 P.M.), NEW YORK CITY TIME, ON THE EVENING OF NOVEMBER 17, 2010, UNLESS EXTENDED. SHARES TENDERED PURSUANT TO THIS EXCHANGE OFFER MAY BE WITHDRAWN AT ANY TIME PRIOR TO THE EXPIRATION OF THE EXCHANGE OFFER.

          On October 15, 2010, St. Jude Medical, Inc. ("St. Jude Medical"), Asteroid Subsidiary Corporation ("Asteroid"), an indirect wholly-owned subsidiary of St. Jude Medical, and AGA Medical Holdings, Inc. ("AGA") entered into an agreement and plan of merger and reorganization (the "Merger Agreement") providing for St. Jude Medical (through an indirect wholly-owned subsidiary) to acquire all of the outstanding shares of AGA common stock by means of an exchange offer (the "Offer") and a subsequent merger (the "Merger") pursuant to the terms and conditions of the Merger Agreement. AGA's board of directors unanimously approved and adopted the Merger Agreement, determined that the Offer and the Merger are fair to, and in the best interests of, AGA's stockholders and recommends that AGA stockholders accept the Offer and tender their shares of AGA common stock pursuant to the Offer. The factors considered by AGA's board of directors in making the determinations and the recommendation described above are set forth in AGA's solicitation/recommendation statement on Schedule 14D-9, which has been filed with the Securities and Exchange Commission (the "SEC") and is being mailed to the AGA stockholders together with this prospectus/offer to exchange. AGA stockholders are encouraged to review carefully the Schedule 14D-9, together with this prospectus/offer to exchange.

          In the Offer, St. Jude Medical, through Asteroid, is offering to exchange for each share of AGA common stock accepted by Asteroid either $20.80 in cash, without interest, or $20.80 in fair market value of St. Jude Medical common stock. AGA stockholders may elect to receive either cash (the "cash election") or St. Jude Medical common stock (the "stock election") for each share of AGA common stock tendered in the Offer. Cash elections and stock elections made in the Offer will be subject to proration.

          The aggregate amount of cash and of St. Jude Medical common stock available to be paid and issued in the Offer will be determined on a 50/50 basis, such that if the holders of more than 50% of the shares of AGA common stock tendered in the Offer elect more than the amount of cash or St. Jude Medical common stock available in either case, AGA stockholders will receive on a pro rata basis the other kind of consideration to the extent the kind of consideration they elect to receive is oversubscribed. For example, if more than 50% of the AGA common stock tendered in the Offer is subject to cash elections, then holders who made cash elections in the aggregate will receive all of the cash available for payment in the Offer (50% of the total consideration payable to all stockholders who tender in the Offer), but also will receive some St. Jude Medical common stock on a pro rata basis, since there would have been an oversubscription for cash.

          Stockholders that tender their shares of AGA common stock, but do not elect to receive cash or to receive St. Jude Medical common stock for their AGA common stock will be treated as if they had made no election and the amount of cash and/or shares of St. Jude Medical common stock that they receive will be based on the amount of cash and/or St. Jude Medical common stock remaining after giving effect to the cash elections and stock elections.

          The fraction of a share or number of shares of St. Jude Medical common stock to be exchanged for each share of AGA common stock for which a stock election has been made will be equal to $20.80 divided by the volume weighted average of the daily closing prices of St. Jude Medical's common stock during the ten trading days ending on and including the second trading day prior to the final expiration date of the Offer (the "exchange rate").

          With respect to the number of shares of St. Jude Medical common stock, if any, to be received by AGA stockholders in exchange for such stockholders' shares of AGA common stock, the exchange rate will be determined in advance of the expiration of the Offer based on the final expiration date of the Offer. St. Jude Medical will announce the exchange rate by issuing a press release no later than 9:00 A.M., New York City time, on the trading day prior to the final expiration date. For example, St. Jude Medical will announce an exchange rate by issuing a press release no later than 9:00 A.M., New York City time, on November 16, 2010 that will apply if the Offer expires at 12:00 midnight (one minute after 11:59 P.M.), New York City time, on the evening of November 17, 2010, the initial expiration date of the Offer. If the Offer is extended, St. Jude Medical will recalculate the exchange rate based on the later expected final expiration date and announce the exchange rate in a similar manner.

          St. Jude Medical's obligation to exchange its common stock for AGA common stock in the Offer is subject to the conditions listed in the section entitled "The Merger Agreement—Conditions to the Offer" on page 117. St. Jude Medical common stock is traded on the New York Stock Exchange (the "NYSE") under the symbol STJ. AGA common stock is traded on the NASDAQ Global Select Market under the symbol AGAM.

          If the Offer is completed, the Offer will be followed by the Merger of Asteroid with and into AGA, in which any remaining shares of AGA common stock not tendered in the Offer will be converted into the right to receive $20.80 in cash, without interest or a fraction of a share or number of shares of St. Jude Medical common stock equal to the exchange rate, except for shares of AGA common stock with respect to which appraisal rights under Delaware law are properly exercised.

          In the Merger, 50% of the shares of AGA common stock exchanged by each holder in the Merger will be exchanged for cash and 50% will be exchanged for shares of St. Jude Medical common stock, subject to adjustment. In no event will the total number of shares of St. Jude Medical common stock to be issued in the Offer and the Merger exceed 19.9% of St. Jude Medical's common stock outstanding on the date on which shares of AGA common stock are first accepted for payment under the Offer. The amount of cash and/or shares of St. Jude Medical common stock payable in the Merger may also be subject to adjustment in the event the Offer, the Merger and the second merger collectively would not qualify as a reorganization under Section 368(a) of the Internal Revenue Code.

          The Merger will entitle AGA stockholders to appraisal rights under the General Corporation Law of the State of Delaware (the "DGCL"). To exercise appraisal rights, an AGA stockholder must strictly comply with all of the procedures under the DGCL. These procedures are described more fully in the section entitled "The Transaction—Appraisal Rights" on page 96.

           See "Risk Factors," beginning on page 25, for a description of certain factors that you should consider in connection with the Offer, as well as related matters described in this prospectus/offer to exchange.

          St. Jude Medical has not authorized any person to provide any information or to make any representation in connection with the Offer other than the information contained or incorporated by reference in this prospectus/offer to exchange, and if any person provides any information or makes any representation of this kind, that information or representation must not be relied upon as having been authorized by St. Jude Medical.

          Neither the SEC nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus/offer to exchange. Any representation to the contrary is a criminal offense.

The date of this prospectus/offer to exchange is November 15, 2010.

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         This prospectus/offer to exchange incorporates by reference important business and financial information about St. Jude Medical from documents filed and to be filed with the SEC that have not been included in or delivered with this prospectus/offer to exchange. You should carefully read and consider all of the documents filed and to be filed by St. Jude Medical with the SEC and to be incorporated by reference into this prospectus/offer to exchange before making an investment decision. This information is available without charge at the SEC's website at www.sec.gov, as well as from other sources. See "Where You Can Find Additional Information" on page 2.

         AGA stockholders also may request copies of these publicly-filed documents from St. Jude Medical, without charge, upon written or oral request to the Corporate Secretary at St. Jude Medical, Inc., One St. Jude Medical Drive, St. Paul, MN 55117, (651) 756-2000. In order to receive timely delivery of the documents, AGA stockholders must make such request no later than November 9, 2010, or five business days before the expiration date, if any extension, of the Offer.

         Commencing on November 1, 2010, this prospectus/offer to exchange will incorporate by reference important business and financial information about AGA from documents filed with the SEC on and after November 1, 2010 that will not be included in or delivered with this prospectus/offer to exchange. You should carefully read and consider all of the documents filed by AGA with the SEC on and after November 1, 2010 and incorporated by reference into this prospectus/offer to exchange before making an investment decision. This information will be available without charge at the SEC's website at www.sec.gov, as well as from other sources. See "Where You Can Find Additional Information" on page 2.

         AGA stockholders also may request copies of these publicly-filed documents from AGA, without charge, upon written or oral request to the Corporate Secretary at AGA Medical Holdings, Inc., 5050 Nathan Lane North, Plymouth, MN 55442, (763) 513-9227. In order to receive timely delivery of the documents, AGA stockholders must make such request no later than November 9, 2010, or five business days before the expiration date, if any extension, of the Offer.

         This prospectus/offer to exchange does not constitute a solicitation of proxies for any meeting of stockholders of AGA. St. Jude Medical is not asking you for a proxy and you are requested not to send in a proxy. Any solicitation of proxies that St. Jude Medical or AGA might make will be made only pursuant to separate proxy solicitation materials complying with the requirements of Section 14(a) of the Securities Exchange Act of 1934, as amended (the "Exchange Act").

         St. Jude Medical and Asteroid will promptly amend the Schedule TO filed with the SEC to reflect any material amendments in the information set forth in such Schedule TO as required by Rule 14d-3(b) under the Exchange Act.

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ANNEXES

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FORWARD-LOOKING STATEMENTS

        Information both included and incorporated by reference in this prospectus/offer to exchange may contain forward-looking statements, concerning, among other things, St. Jude Medical, Inc.'s ("St. Jude Medical") business strategies or the financial projections of AGA Medical Holdings, Inc. ("AGA"), which are subject to risks, uncertainties and assumptions. St. Jude Medical intends these forward-looking statements to be covered by the safe harbor provided by the Private Securities Litigation Reform Act of 1995 to the fullest extent permitted by such act.

        Forward-looking statements are statements that are not historical facts, and include statements regarding the timing of the transaction and the consideration to be received by the stockholders of AGA, the successful integration of the AGA business into St. Jude Medical, the expansion of St. Jude Medical's product offerings, St. Jude Medical's presence in the medical devices market, the enhancement of value and benefits to physician customers and to St. Jude Medical's and AGA's stockholders, and the ability to realize growth and efficiencies as a result of the Offer and the Merger. These forward-looking statements are identified by their use of terms such as "intend," "plan," "may," "should," "will," "anticipate," "believe," "could," "estimate," "expect," "continue," "potential," "opportunity," "project," "strategy" and similar terms. These statements are based on certain assumptions and analyses that St. Jude Medical believes are appropriate under the circumstances, and are subject to various risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should the assumptions prove incorrect, actual results may differ materially from those expected, estimated, projected, or implied in these forward-looking statements. St. Jude Medical cannot guarantee that it actually will achieve these plans, intentions or expectations, or complete the Offer and the Merger on the terms summarized in this prospectus/offer to exchange. The risks and uncertainties that could have a material adverse effect on St. Jude Medical's operations and future prospects or the completion of the Offer and the Merger include, but are not limited to:

•

the failure to satisfy the conditions to consummate the Offer and the Merger;



•

the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger Agreement;



•

the failure of the Offer or the Merger to close for any other reason;



•

the amount of the costs, fees, expenses and charges related to the Offer and the Merger;



•

the failure of St. Jude Medical to integrate AGA successfully;



•

general economic and business conditions;



•

global economic growth and activity;



•

industry conditions; and



•

changes in laws or regulations.

        These risks and uncertainties, along with the risk factors discussed under "Risk Factors" in this prospectus/offer to exchange, should be considered in evaluating any forward-looking statements contained in this prospectus/offer to exchange. All forward-looking statements speak only as of the date of this prospectus/offer to exchange, and, except as required by law, St. Jude Medical undertakes no obligation to publicly update or revise any of them in light of new information, future events or otherwise. All subsequent written and oral forward-looking statements attributable to St. Jude Medical or AGA or any person acting on their behalf are qualified by the cautionary statements in this section.

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WHERE YOU CAN FIND ADDITIONAL INFORMATION

         This prospectus/offer to exchange incorporates and will incorporate documents by reference that are not presented in or delivered with this prospectus/offer to exchange. You should rely only on the information contained in this prospectus/offer to exchange and in the documents that St. Jude Medical has incorporated by reference and that AGA will incorporate by reference into this prospectus/offer to exchange. St. Jude Medical has not authorized anyone to provide you with information that is different from or in addition to the information contained in, or incorporated by reference into, this prospectus/offer to exchange.

        St. Jude Medical and AGA file annual, quarterly and current reports, proxy statements and other information with the SEC. The public may read and copy any reports, statements or other information that St. Jude Medical or AGA file with the SEC at the SEC's public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information regarding the public reference room. St. Jude Medical's and AGA's public filings also are available to the public from commercial document retrieval services and may be obtained without charge at the SEC's website at www.sec.gov. St. Jude Medical's and AGA's filings with the SEC are also available on their websites at www.sjm.com and www.amplatzer.com , respectively. The contents of those websites are not incorporated by reference into this prospectus/offer to exchange.

        St. Jude Medical has filed with the SEC a registration statement on Form S-4 ("Form S-4") to register the offer and sale of shares of St. Jude Medical common stock to be issued in the Offer and the Merger. This prospectus/offer to exchange is a part of that registration statement. St. Jude Medical may also file amendments to such registration statement. In addition, on October 20, 2010, St. Jude Medical filed with the SEC a Tender Offer Statement on Schedule TO ("Schedule TO") under the Exchange Act, together with exhibits, to furnish certain information about the Offer. St. Jude Medical may file amendments to the Schedule TO. As allowed by SEC rules, this prospectus/offer to exchange does not contain all of the information in the registration statement or the exhibits to the registration statement. You may obtain copies of the Form S-4 and Schedule TO (and any amendments to those documents) by contacting St. Jude Medical at the following address:

St. Jude Medical
One St. Jude Medical Drive
St. Paul, MN 55117
Attention: Corporate Secretary
(651) 756-2000

        St. Jude Medical has engaged Georgeson Inc. to act as its information agent in connection with the Offer. You can obtain copies of the Form S-4 and Schedule TO (and any amendments to those documents) along with the related letter of election and transmittal by contacting Georgeson Inc. at the following address:

Georgeson Inc.
199 Water Street—26th Floor
New York, NY 10038-3560
Banks and Brokers Call: (212) 440-9800
All Others Call Toll Free: (877) 278-4774

        On October 20, 2010, AGA filed with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9 under the Exchange Act ("Schedule 14D-9"), together with exhibits containing the AGA board of director's recommendation with respect to the Offer and certain additional information about the Offer. AGA may file amendments to the Schedule 14D-9. You may obtain copies of the Schedule 14D-9 (and any amendments thereto) by contacting AGA at the following address:

AGA Medical Holdings, Inc.
5050 Nathan Lane North
Plymouth, MN 55442
(763) 513-9227

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INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE

        The following documents filed by St. Jude Medical with the SEC are incorporated by reference into this prospectus/offer to exchange. You should carefully read and consider all of these documents before making an investment decision.

•

Annual Report on Form 10-K for the year ended January 2, 2010, filed on March 2, 2010;



•

Quarterly Reports on Form 10-Q for the fiscal quarters ended April 3, 2010 and July 3, 2010, filed on May 4, 2010 and August 11, 2010, respectively;



•

Current Reports on Form 8-K, filed on January 15, 2010, January 25, 2010, March 15, 2010, March 19, 2010, May 7, 2010, October 18, 2010 and October 26, 2010;



•

The following information from Exhibit 99.1 to the Current Report on Form 8-K furnished on October 20, 2010: (i) The following line items from the table under the heading "St. Jude Medical, Inc. Condensed Consolidated Statements of Earnings: Net Sales through Net earnings, Diluted net earnings per share and Weighted average shares outstanding—diluted and (ii) the information in the table under the heading "Condensed Consolidated Balance Sheets."



•

Proxy Statement for 2010 Annual Meeting of Shareholders, filed on March 23, 2010; and



•

Description of St. Jude Medical common stock set forth in its Registration Statements on Form 8-A, filed on April 28, 1978 and November 8, 1996, including any amendment or report filed for purposes of updating such description.

        All documents filed by St. Jude Medical with the SEC pursuant to Sections 13(a), 13(c), 14, or 15(d) of the Exchange Act after the filing of this document, including documents filed on and after the date of this document and prior to the effectiveness of the Form S-4 to which this document relates, and prior to the date the Offer is terminated, are incorporated by reference into this prospectus/offer to exchange and are part of this document from the date of filing. You should carefully read and consider all of the documents to be filed with the SEC by St. Jude Medical after the filing of this document and to be incorporated by reference into this prospectus/offer to exchange before making an investment decision.

        St. Jude Medical and Asteroid will promptly amend the Schedule TO filed with the SEC to reflect any material amendments in the information set forth in such Schedule TO as required by Rule 14d-3(b) under the Exchange Act.

        All documents filed by AGA with the SEC pursuant to Sections 13(a), 13(c), 14, or 15(d) of the Exchange Act on and after November 1, 2010 will be incorporated by reference into this prospectus/offer to exchange and will be part of this document from the date of filing. You should carefully read and consider all of the documents to be filed with the SEC by AGA on and after November 1, 2010 and to be incorporated by reference into this prospectus/offer to exchange before making an investment decision.

        Nothing in this prospectus/offer to exchange shall be deemed to incorporate herein any information furnished but not filed with the SEC.

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QUESTIONS AND ANSWERS ABOUT THE PROPOSED TRANSACTION

         Below are some of the questions that you as a holder of AGA common stock may have regarding the Offer and the Merger and answers to those questions. You are urged to carefully read the remainder of this prospectus/offer to exchange and the related letter of election and transmittal and the other documents to which we have referred, because the information contained in this section and in the "Summary" section is not complete. Additional important information is contained in the remainder of this prospectus/offer to exchange, the related letter of election and transmittal, and the documents incorporated herein. See "Where You Can Find Additional Information" on page 2.

         As used in this prospectus/offer to exchange, unless otherwise indicated or the context requires, "St. Jude Medical" refers to St. Jude Medical, Inc. and its consolidated subsidiaries, and "AGA" refers to AGA Medical Holdings, Inc. and its consolidated subsidiaries.

Q:

What are St. Jude Medical and AGA proposing to do?

A:

St. Jude Medical and AGA entered into a Merger Agreement on October 15, 2010, pursuant to which St. Jude Medical, through its indirect wholly-owned subsidiary Asteroid Subsidiary Corporation ("Asteroid"), is offering to exchange cash or shares of St. Jude Medical common stock for all of the outstanding shares of AGA common stock (the "Offer"). As of October 13, 2010, AGA had 50,268,924 shares of common stock outstanding, all of which St. Jude Medical seeks to acquire in the Offer. In addition, there were 3,235,962 shares of AGA common stock subject to options outstanding as of October 13, 2010 (the "Options"), some of which are exercisable or may become exercisable prior to the expiration of the Offer, and 251,100 shares of AGA common stock subject to restricted stock units (the "RSUs"), some of which have vested or may vest prior to the expiration of the Offer. To the extent these Options or RSUs are exercised or vest in exchange for shares of AGA common stock prior to the expiration of the Offer, St. Jude Medical will seek to acquire the shares issued upon such exercise in the Offer. Promptly after completion of the Offer, St. Jude Medical intends to merge Asteroid with and into AGA (the "Merger"). As a result of the Merger, the separate corporate existence of Asteroid will cease and AGA will continue as the surviving corporation of the Merger and an indirect wholly-owned subsidiary of St. Jude Medical.

Options and RSUs to purchase shares of AGA common stock are not subject to the Offer, but will be canceled in connection with the Merger in exchange for which certain cash payments will be made to holders of canceled Options and RSUs. In addition, as of October 13, 2010, 28,725 shares were subject to purchase under AGA's employee stock purchase plan. All rights under this employee stock purchase plan shall be cancelled in exchange for cash payments upon consummation of the Merger.

Q:

What would I receive in exchange for my shares of AGA common stock?

A:

In the Offer, St. Jude Medical, through its indirect wholly-owned subsidiary, Asteroid, is offering to exchange for each share of AGA common stock that is validly tendered and not withdrawn either:

•

$20.80 in cash, without interest (the "Cash Consideration"); or

•

a fraction of a share or shares of St. Jude Medical common stock equal to the exchange rate (the "Stock Consideration"), which is $20.80 divided by the St. Jude Medical volume weighted average of the daily closing prices, determined by closing prices on the New York Stock Exchange for the ten trading days ending on and including the second trading day preceding the expected final expiration date of the Offer (the "Average Trading Price"), subject to adjustment and proration, as described in this prospectus/offer to exchange and the related letter of election and transmittal. For purposes of calculating the exchange rate, the trading volume of St. Jude

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Medical common stock will be based on the consolidated trading volume across all U.S. exchanges. This consolidated trading volume is reported for St. Jude Medical on bloomberg.com under "Volume." You may elect to receive either cash (the "cash election"), or St. Jude Medical common stock ("stock election") for each of your shares of AGA common stock tendered in the Offer. You can elect cash for some of your shares and stock for others. If you tender your shares of AGA common stock, but do not elect to receive cash or to receive St. Jude Medical common stock for your AGA common stock, you will be treated as if you had made no election, and you will receive consideration as described in response to the question "What will happen if I tender my shares but do not make an election?"

The exchange rate will be determined in advance of the expiration of the Offer based on the date on which St. Jude Medical will accept shares of AGA common stock for exchange pursuant to the Offer, which we refer to as the final expiration date. St. Jude Medical will announce the exchange rate by issuing a press release no later than 9:00 A.M., New York City time, on the trading day prior to the expected final expiration date of the Offer. For example, St. Jude Medical will announce the exchange rate by issuing a press release no later than 9:00 A.M., New York City time, on November 16, 2010 that will apply if the Offer expires at 12:00 midnight (one minute after 11:59 P.M.), New York City time, on the evening of November 17, 2010, the initial expiration date of the Offer. If the Offer is extended, St. Jude Medical will recalculate the exchange rate based on the later expected final expiration date and announce the exchange rate in a similar manner.

The aggregate amount of cash and number of shares of St. Jude Medical common stock payable in the Offer are subject to the following limits:

•

The maximum amount of cash payable in the Offer is $20.80 multiplied by 50% of the aggregate number of shares of AGA common stock tendered in the Offer. Thus, 50% of the shares of AGA common stock tendered in the Offer will be exchanged for cash.



•

The maximum number of shares of St. Jude Medical common stock payable in the Offer is the exchange rate multiplied by 50% of the aggregate number of number of shares of AGA common stock tendered in the Offer. Thus, 50% of the shares of AGA common stock tendered in the Offer will be exchanged for shares of St. Jude Medical common stock.



•

In no event will the number of shares of St. Jude Medical common stock to be paid in the Offer and the Merger exceed 19.9% of shares of St. Jude Medical common stock outstanding on the final expiration date.

Therefore, elections will be subject to proration if tendering holders of AGA common stock, in the aggregate, elect to receive more than the maximum amount of consideration to be paid as cash or shares of St. Jude Medical common stock.

The fractional shares of St. Jude Medical common stock to which an AGA stockholder is entitled in the Offer or the Merger shall be aggregated with all other fractional shares of all other AGA stockholders in the Offer or Merger, as applicable. Those aggregated shares will be sold in the open market by the exchange agent, as agent for the AGA stockholders having an interest in those shares, and those AGA stockholders will be entitled to their proportional share of the cash proceeds, without interest, from that sale.

Q:

Is the Offer being made by St. Jude Medical or Asteroid?

A:

The Offer is technically being made by Asteroid, which was formed by St. Jude Medical specifically for the purpose of making the Offer and otherwise facilitating the transaction. Because Asteroid is an indirect wholly-owned subsidiary of St. Jude Medical, all of the shares of AGA common stock acquired by Asteroid in the Offer will actually be beneficially owned and indirectly controlled by

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St. Jude Medical. Therefore, although Asteroid is technically making the Offer and is a party to the Merger, when we discuss the Offer and the Merger, we generally refer only to St. Jude Medical.

Q:

How long will it take to complete the Offer and the Merger?

A:

St. Jude Medical hopes to complete the Offer in mid-November 2010. St. Jude Medical expects to complete the Merger shortly after it completes the Offer, or, if the approval of the stockholders of AGA for the Merger is required, shortly after the special meeting of AGA stockholders to approve the Merger.

Q:

Do I have to pay any brokerage fees or commissions?

A:

If you are the record owner of your shares and you tender your shares in the Offer, you will not incur any brokerage fees or commissions. If you own your shares through a broker or other nominee who tenders the shares on your behalf, your broker or other nominee may charge you a commission for doing so. You should consult with your broker or other nominee to determine whether any charges will apply.

Q:

Does AGA's board of directors support the Offer and the Merger?

A:

Yes. AGA's board of directors unanimously approved the Offer and the Merger and recommends that you tender your shares of AGA common stock in the Offer. Information about the recommendation of AGA's board of directors is described in AGA's Solicitation/Recommendation Statement on Schedule 14D-9, which is being mailed to you together with this prospectus/offer to exchange.

Q:

Have any of the stockholders of AGA agreed to tender their shares?

A:

Yes. Stockholders of AGA affiliated with Welsh, Carson, Anderson & Stowe ("Welsh Carson") and Franck Gougeon entered into a tender and voting agreement pursuant to which they have agreed to tender into the exchange offer an aggregate of 32,808,507 shares of AGA common stock, which represent approximately 65% of the common stock of AGA outstanding as of October 13, 2010. In the event that the AGA board of directors withdraws or adversely changes its recommendation in favor of the Offer and the Merger, or terminates the Merger Agreement to enter into an agreement with respect to a superior proposal, in each case in accordance with the terms of the Merger Agreement, the shares of AGA common stock subject to the tender and voting agreement in excess of the aggregate of 30% of the outstanding common stock of AGA on a fully diluted basis at that time will be released from the obligations under the tender and voting agreement, which we call a "tender and voting agreement release."

Q:

What percentage of St. Jude Medical common stock will AGA stockholders own after the Merger?

A:

If St. Jude Medical obtains all of the shares of AGA common stock pursuant to the transaction, former stockholders of AGA would own approximately 3.83% of the shares of common stock of St. Jude Medical, based upon the number of shares of St. Jude Medical common stock and AGA common stock outstanding on October 13, 2010, not taking into account Options, RSUs or other rights to acquire common stock of AGA or St. Jude Medical, and assuming the Average Trading Price for St. Jude Medical's shares as finally calculated for purposes of the Offer is approximately $39.90, which was the closing price on October 15, 2010.

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Q:

What are the most significant conditions to the completion of the Offer?

A:

St. Jude Medical's obligation to accept shares of AGA common stock for exchange is subject to several conditions that must be satisfied or waived by Asteroid prior to the expiration of the offer, including:

•

there having been validly tendered and not withdrawn (not including shares of AGA common stock subject to a notice of guaranteed delivery unless such shares have actually been delivered) prior to the expiration date of the Offer, a number of shares of AGA common stock, which, together with any shares of AGA common stock that St. Jude Medical, Asteroid or any other subsidiary of St. Jude Medical owns, constitute at least a majority of the total number of outstanding shares of AGA common stock on a fully diluted basis (as though all rights and convertible securities convertible into or exercisable for shares of AGA common stock had been so converted or exercised), which is referred to in this prospectus/offer to exchange as the "minimum condition;"

•

the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the "HSR Act"), and under applicable foreign antitrust laws;

•

the registration statement of which this prospectus/offer to exchange is a part having been declared effective by the SEC and no stop order suspending the effectiveness of the registration statement having been issued by the SEC;

•

the shares of St. Jude Medical common stock to be issued in the Offer having been approved for listing on the NYSE;

•

AGA having not breached or failed to comply in any material respect with any of its obligations, covenants or agreements in the Merger Agreement;

•

the representations and warranties of AGA contained in the Merger Agreement having been true and correct as of the date of the Merger Agreement and as of the time for acceptance and payment of the shares (except to the extent such representations and warranties expressly relate to an earlier date, in which case as of such earlier date), subject to applicable materiality qualifications;

•

no action by any governmental entity or law that prohibits the Offer or the Merger or imposes material limitations on St. Jude Medical's ownership of the shares of AGA having been taken or enacted;

•

no event having occurred that has had or would reasonably be expected to have a material adverse effect on AGA;

•

all of the directors (other than three independent directors) having resigned immediately prior to St. Jude Medical's acceptance of AGA shares for exchange; and

•

the Merger Agreement not having been terminated.

The minimum condition will be a majority of 53,784,711 shares of AGA common stock, which is equal to the sum of the total number of outstanding shares of AGA common stock and the total number of shares of AGA common stock issuable upon the exercise of all outstanding Options and RSUs to purchase AGA common stock and employee stock purchase plan rights. Other than the Options, RSUs and employee stock purchase plan rights, there are no rights or other securities convertible into or exercisable for shares of AGA common stock outstanding. As a result, there must be validly tendered and not withdrawn 26,892,357 shares of AGA common stock in the Offer to satisfy the minimum condition. Assuming that the stockholders of AGA who have entered into the tender and voting agreement tender or cause to be tendered all of the shares they beneficially

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owned as of October 13, 2010, no additional shares of AGA common stock must be tendered in the Offer to satisfy the minimum condition unless there is a tender and voting agreement release. If there is a tender and voting agreement release, an additional 10,756,944 shares of AGA common stock, representing approximately 20.0% of the sum of outstanding shares and shares issuable upon exercise of Options, RSUs and employee stock purchase plan rights, or 21.4% of the outstanding shares of AGA common stock (excluding shares issuable upon exercise of Options, RSUs and employee stock purchase plan rights) as of October 13, 2010, must be tendered into the Offer to satisfy the minimum condition.

These and other conditions to the Offer are discussed in this prospectus/offer to exchange in the section entitled "The Merger Agreement—Conditions to the Offer" beginning on page 117.

Q:

How do I participate in the Offer?

A:

You are urged to read this entire prospectus/offer to exchange carefully, and to consider how the Offer and the Merger affect you. Then, if you wish to tender your shares of AGA common stock, you should complete and sign the enclosed letter of election and transmittal and return it with your stock certificates to Wells Fargo Shareowner Services, the designated exchange agent, or, if you hold your shares in "street name" through a broker or other nominee, ask your broker or other nominee to tender your shares. Please read this prospectus/offer to exchange carefully for more information about the procedures for tendering your shares, making a cash election or a stock election, the timing of the Offer, extensions of the Offer period and your rights to withdraw your shares from the Offer prior to the expiration date.

Q:

What will happen if I tender my shares but do not make an election?

A:

AGA stockholders who tender their shares of AGA common stock, but do not make an election will be allocated whatever form of Offer consideration is remaining (or a proportionate share of each form of Offer consideration if neither is oversubscribed), after taking into account the preferences of the tendering stockholders who made valid elections, as follows. If 50% or more of the aggregate number of shares of AGA common stock tendered in the Offer have made a valid election to receive cash, AGA stockholders who do not make an election will be treated as though they had elected to receive St. Jude Medical common stock. If 50% or more of the aggregate number of shares of AGA common stock tendered in the Offer have made a valid election to receive shares of St. Jude Medical common stock, AGA stockholders who do not make an election will be treated as though they had elected to receive cash. If neither form of consideration is oversubscribed, AGA stockholders who do not make an election will each receive the remaining cash and shares of St. Jude Medical common stock after taking into account all valid elections on a pro rata basis, such that after all shares of AGA common stock are exchanged, 50% of the aggregate shares of AGA common stock tendered in the Offer will have been exchanged for cash and 50% of the aggregate shares of AGA common stock tendered in the Offer will have been exchanged for shares of St. Jude Medical common stock.

Q:

What will happen if I do not tender my shares of AGA common stock?

A:

If, after completion of the Offer, St. Jude Medical owns a majority of the outstanding shares of AGA common stock, it intends to complete a Merger of its indirect wholly-owned subsidiary, Asteroid, with and into AGA. Upon consummation of the Merger, except for shares of AGA common stock with respect to which appraisal rights under Delaware law are properly exercised, each share of AGA common stock that has not been tendered and accepted for exchange in the Offer will be converted in the Merger into the right to receive either the Cash Consideration or the Stock Consideration. 50% of the shares of AGA common stock will be converted in the Merger into the right to receive the Cash Consideration and 50% will be converted into the right

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to receive the Stock Consideration, subject to adjustment as described in this prospectus/offer to exchange and the related letter of transmittal to be sent following the Merger. The fractional shares of St. Jude Medical common stock to which an AGA stockholder is entitled in the Merger shall be aggregated with all other fractional shares of all other AGA stockholders in the Merger. Those aggregated shares will be sold in the open market by the exchange agent, as agent for the AGA stockholders having an interest in those shares, and those AGA stockholders will be entitled to their proportional share of the cash proceeds, without interest, from that sale.

Q:

Will I be taxed on the cash or St. Jude Medical shares I receive?

A:

The tax consequences to AGA stockholders who receive shares of St. Jude Medical common stock and/or cash in exchange for AGA common stock if the transaction constitutes a reorganization within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended (the "Internal Revenue Code") will generally be as follows:

•

AGA stockholders who exchange all of their AGA common stock for St. Jude Medical common stock in the Offer or the Merger will not recognize any gain or loss from the exchange, except with respect to cash proceeds received upon the sale of a fractional share of St. Jude Medical common stock;

•

AGA stockholders who exchange all of their AGA common stock for cash in the Offer or the Merger generally will recognize gain or loss in the exchange equal to the difference between the aggregate amount of cash received for the AGA common stock and the stockholder's tax basis in the AGA common stock; and

•

AGA stockholders who exchange their AGA common stock for both St. Jude Medical common stock and cash in the Offer or the Merger will recognize gain, but not loss in the exchange, equal to the lesser of (a) the amount of cash received in the transaction (other than cash attributable to the proceeds from the sale of a fractional share of St. Jude Medical common stock) and (b) the amount of gain realized in the transaction. The amount of gain that is realized in the exchange will equal the excess of (i) the sum of the cash plus the fair market value of the St. Jude Medical common stock received in the exchange over (ii) the tax basis of the AGA common stock surrendered in the transaction. These AGA stockholders will also recognize gain or loss with respect to the sale of any fractional share of St. Jude Medical common stock received.

If the St. Jude Medical common stock price as of the completion of the Offer or the second merger is significantly lower than the price of St. Jude Medical stock as calculated for purposes of determining the exchange rate, or if appraisal rights are exercised, there may be a risk that the Offer and the Merger would not qualify as part of a reorganization within the meaning of Section 368(a) of the Internal Revenue Code. In such circumstance, based on the adjustment provisions in the Merger Agreement, more AGA common stock exchanged in the Merger will be converted into a right to receive Stock Consideration in place of some or all of the AGA common stock that would have been converted into a right to receive Cash Consideration so that the aggregate value of the St. Jude Medical common stock issued in the transaction constitutes at least 40% of the aggregate value of the cash and St. Jude Medical common stock paid and issued in the Offer and Merger. If it is not possible to increase the aggregate value of the St. Jude Medical common stock issued in the transaction to this level, the transaction would be treated as a taxable sale of AGA common stock for U.S. federal income tax purposes, and no adjustment would be made to the amount of Cash Consideration paid in the Merger for this purpose. Upon completion of the Merger, St. Jude Medical plans to issue a press release as to whether the Offer and the Merger should qualify as part of a reorganization within the meaning of Section 368(a) of the Internal Revenue Code.

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You should carefully read the discussion under "Material U.S. Federal Income Tax Consequences." Tax matters are very complicated and the tax consequences to you of the Offer, the Merger and the second merger of AGA with and into a wholly-owned subsidiary of St. Jude Medical, as described below, will depend on the facts of your own situation, as well as facts that will not be known until after the Offer has been completed and the Merger has occurred. You are urged to consult your own tax advisor for a full understanding of the tax consequences of participating in the Offer or the Merger.

Q:

Do the statements on the cover page that the information in this prospectus/offer to exchange may change and that the registration statement filed with the SEC is not yet effective mean that the Offer has not yet commenced?

A:

No. The Offer has commenced and effectiveness of the registration statement is not necessary for you to tender your shares of AGA common stock.

Q:

Where can I find more information about St. Jude Medical and AGA?

A:

You can find more information about St. Jude Medical and AGA as described in the section entitled "Where You Can Find Additional Information" on page 2 of this prospectus/offer to exchange.

Q:

Whom should I contact if I have more questions about the transaction?

A:

If you have questions about the transaction, or to obtain the indicative exchange rate starting on November 1, 2010, and the exchange rate starting on November 16, 2010, please contact our information agent, Georgeson Inc., at (212) 440-9800 (banks and brokers) or toll free at (877) 278-4774 (all others).

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SUMMARY

         This section summarizes material information presented in greater detail elsewhere in this prospectus/offer to exchange. However, this summary does not contain all of the information that may be important to AGA stockholders. AGA stockholders are urged to read carefully the entire prospectus/offer to exchange and the other documents referred to and incorporated by reference in this prospectus/offer to exchange to fully understand the Offer and the Merger. In particular, AGA stockholders should read the Merger Agreement, which is attached as Annex A. You may obtain the information incorporated by reference into this prospectus/offer to exchange by following the instructions in the section entitled, "Where You Can Find Additional Information."

The Transaction (Page 65)

        St. Jude Medical and AGA entered into the Merger Agreement on October 15, 2010, pursuant to which an indirect wholly-owned subsidiary of St. Jude Medical, Asteroid, is offering to exchange cash and shares of St. Jude Medical common stock for all of the outstanding shares of AGA common stock. In the Offer, Asteroid is offering to exchange cash in the amount of $20.80 or a fraction of a share or shares of St. Jude Medical common stock having a value equal to $20.80 for each share of AGA common stock that is validly tendered and not withdrawn. This amount of St. Jude Medical common stock shall be referred to as the exchange rate. The exchange rate will be determined in advance of the expiration of the Offer based on the final expiration date of the Offer. The exchange rate will be equal to $20.80 divided by the Average Trading Price. The Average Trading Price is the volume weighted average of the daily closing sale prices per share of St. Jude Medical common stock on the NYSE for the ten trading days ending on and including the second trading day preceding the final expiration date of the Offer. For purposes of calculating the exchange rate, the trading volume of St. Jude Medical common stock will be based on the consolidated trading volume across all U.S. exchanges. This consolidated trading volume is reported for St. Jude Medical on bloomberg.com under "Volume." Based on $39.63, which is the Average Trading Price of St. Jude Medical common stock on the New York Stock Exchange (the "NYSE") for the ten trading days up to and including the second trading day prior to October 19, 2010, the exchange rate would be 0.525. AGA stockholders may contact St. Jude Medical's information agent toll free to obtain the indicative exchange rate starting on November 1, 2010, and the exchange rate starting on November 16, 2010. AGA stockholders may elect to receive cash or shares of St. Jude Medical common stock, for all of their shares of AGA common stock tendered in the Offer, subject to proration in the event the amount of cash or St. Jude Medical common stock available in the Offer is oversubscribed.

        Pursuant to the Merger Agreement, the initial expiration date for the Offer is November 17, 2010. In certain circumstances, St. Jude Medical is required to or may extend the Offer beyond this date.

        Promptly after completion of the Offer, St. Jude Medical intends to merge Asteroid with and into AGA. Each share of AGA common stock that has not been tendered and accepted for payment in the Offer will be converted in the Merger into the right to receive $20.80 in cash, without interest, or a fraction of a share or number of shares of St. Jude Medical common stock equal to the exchange rate, except for shares of AGA common stock with respect to which appraisal rights under Delaware law are properly exercised, treasury shares and shares that St. Jude Medical or Asteroid holds for its own account. 50% of the AGA shares converted in the Merger will receive the Cash Consideration and 50% will receive the Stock Consideration, subject to adjustment in the event the Offer and the Merger collectively would not otherwise qualify as a reorganization within the meaning of Section 368(a) of the Internal Revenue Code. As a result of the Merger, the separate corporate existence of Asteroid shall cease and AGA shall continue as the surviving corporation of the Merger. St. Jude Medical seeks to acquire ownership of 100% of the outstanding shares of AGA common stock through the Offer and the Merger. The Offer and the Merger are sometimes collectively referred to in this prospectus/offer to exchange as the "transaction."

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        After completion of the Merger of Asteroid into AGA, St. Jude Medical will cause AGA to be merged with and into a wholly-owned subsidiary of St. Jude Medical (the "second merger"), unless the value of the cash paid in the transaction constitutes more than 60% of the aggregate value of the cash and St. Jude Medical common stock paid and issued in the transaction such that the transaction would not qualify as a reorganization within the meaning of Section 368(a) of the Internal Revenue Code.

Purpose of the Offer (Page 66)

        St. Jude Medical is making the Offer in order to acquire all of the outstanding shares of AGA common stock. St. Jude Medical intends, as soon as practicable after completion of the Offer, to have its indirect wholly-owned subsidiary, Asteroid, the purchaser in the Offer, merge with and into AGA. The purpose of the Merger is to acquire all shares of AGA common stock not tendered and exchanged in connection with the Offer. In the Merger, each then outstanding share of AGA common stock, except for treasury shares, shares that St. Jude Medical or Asteroid holds for its own account and shares of AGA common stock with respect to which appraisal rights have been properly exercised under Delaware law, will be converted into the right to receive, the Cash Consideration or the Stock Consideration. 50% of the AGA shares converted in the Merger will receive the Cash Consideration and 50% will receive the Stock Consideration, subject to adjustment in certain circumstances.

The Companies (Page 126)

St. Jude Medical, Inc.

St. Jude Medical, Inc.
One St. Jude Medical Drive
St Paul, MN 55117
(651) 756-2000

        St. Jude Medical develops, manufactures and distributes cardiovascular medical devices for the global cardiac rhythm management, cardiology and cardiac surgery and atrial fibrillation therapy areas and neurostimulation medical devices for the management of chronic pain. St. Jude Medical's four operating segments are Cardiac Rhythm Management (CRM), Cardiovascular (CV), Atrial Fibrillation (AF) and Neuromodulation (NMD). St. Jude Medical's CV operating segment focuses on both the cardiology and cardiac surgery therapy areas. St. Jude Medical's principal products in each operating segment are as follows: CRM—tachycardia implantable cardioverter defibrillator systems (ICDs) and bradycardia pacemaker systems (pacemakers); CV—vascular closure devices, heart valve replacement and repair products and pressure measurement guidewires; AF—electrophysiology (EP) introducers and catheters, advanced cardiac mapping, navigation and recording systems and ablation systems; and NMD—neurostimulation devices. The company markets and sells its products through both a direct sales force and independent distributors. The principal geographic markets for its products are the United States, Europe, Japan and Asia Pacific. St. Jude Medical was incorporated in Minnesota in 1976. Its common stock is traded on the New York Stock Exchange under the symbol STJ.

Asteroid Subsidiary Corporation

Asteroid Subsidiary Corporation
c/o St. Jude Medical Inc.
One St. Jude Medical Drive
St Paul, MN 55117
(651) 756-2000

        Asteroid is an indirect wholly-owned subsidiary of St. Jude Medical and was incorporated on October 12, 2010 in the State of Delaware. Asteroid has not engaged in any operations and exists solely to make the Offer and otherwise facilitate the transaction. Therefore, although Asteroid is technically

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making the Offer and will be a party to the Merger, when the transaction is discussed in this prospectus/offer to exchange, it generally refers only to St. Jude Medical.

AGA Medical Holdings, Inc.

AGA Medical Holdings, Inc.
5050 Nathan Lane North
Plymouth, MN 55442
(763) 513-9227

        AGA, based in Plymouth, Minnesota, is a leading innovator and manufacturer of medical devices for the treatment of structural heart defects and vascular abnormalities. AGA's AMPLATZER® occlusion devices offer minimally invasive, transcatheter treatments that have been clinically shown to be safe and highly effective in defect closure. AGA is the only manufacturer with occlusion devices approved to close seven different structural heart defects, with leading market positions for each of its devices. More than 1,650 articles supporting the benefits of AMPLATZER products have been published in medical literature. AGA markets its AMPLATZER products in 112 countries worldwide to interventional cardiologists, electrophysiologists, interventional radiologists and vascular surgeons. AGA's predecessor and subsidiary, AGA Medical Corporation, was founded in Minnesota in 1995. AGA was incorporated in 2005 in Delaware. Its common stock is traded on the NASDAQ Global Select Market under the symbol AGAM.

Timing of the Offer (Page 67)

        The Offer commenced on October 20, 2010 and is currently scheduled to expire on November 17, 2010, but may be extended under the circumstances described below.

Extension; Termination or Amendment (Page 67)

        Subject to the terms of the Merger Agreement, the Offer:

•

shall be extended by St. Jude Medical (but not later than March 1, 2011) if any of the conditions to the Offer shall not have been satisfied or waived;



•

may be extended by St. Jude Medical if and to the extent required by the SEC, NASDAQ or the NYSE or any other applicable law; and



•

may be extended once by St. Jude Medical (but not later than March 1, 2011) if all of the conditions to the Offer shall have been satisfied or waived, but less than 90% of the shares of AGA common stock on a fully diluted basis have been tendered in the Offer.

        During an extension, all shares of AGA common stock previously tendered and not properly withdrawn will remain subject to the Offer, subject to an AGA stockholder's right to withdraw its shares of AGA common stock. If the Offer has not been consummated by March 1, 2011, AGA or St. Jude Medical may terminate the Merger Agreement.

Withdrawal Rights (Page 70)

        Shares of AGA common stock tendered pursuant to the Offer may be withdrawn at any time prior to the expiration date of the Offer, as it may be extended.

Procedure for Tendering (Page 71)

        For an AGA stockholder to validly tender shares of AGA common stock pursuant to the Offer and make a cash election or stock election, a properly completed and duly executed letter of election and transmittal or manually executed copy of that document, along with any required signature guarantees,

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or an agent's message in connection with a book-entry transfer, and any other required documents, must be transmitted to and received by Wells Fargo Shareowner Services, the designated exchange agent, at Corporate Actions Department, P.O. Box 64858, St. Paul, MN 55164-0858 (post office mailing address), or, to Corporate Actions Department, 161 North Concord Exchange, South St. Paul, MN 55075 (overnight/hand delivery). Alternatively, an AGA stockholder may comply with the guaranteed delivery procedures set forth in the section entitled "The Transaction—Procedure for Tendering."

        In addition, certificates for tendered shares of AGA common stock must be received by the exchange agent at one of these addresses, or the shares of AGA common stock must be tendered pursuant to the procedures for book-entry tender, in each case before the expiration date of the Offer.

Exchange of Shares of AGA Common Stock; Delivery of Cash and Shares of St. Jude Medical Common Stock (Page 69)

        Upon the terms of, and subject to the conditions to, the Offer, including, if the Offer is extended or amended, the terms and conditions of any extension or amendment, St. Jude Medical is required to accept for exchange, and to deliver cash and shares of St. Jude Medical common stock in exchange for, shares of AGA common stock validly tendered and not withdrawn, promptly after the expiration date of the Offer.

Elections and Prorations (Page 68)

        If you wish to make a cash election or a stock election, you must make a cash election or stock election when you tender shares of AGA common stock pursuant to the Offer to the exchange agent with your letter of election and transmittal.

Top-Up Option (Page 66)

        Pursuant to the Merger Agreement, AGA has granted to St. Jude Medical an irrevocable option to purchase newly-issued shares of AGA common stock in an amount up to the lowest number of shares of AGA common stock that, when added to the aggregate number of shares of AGA common stock owned by St. Jude Medical and Asteroid, will constitute one share of AGA common stock more than 90% of the total shares of AGA commons stock outstanding (the "Top-Up Option"). Subject to applicable legal and regulatory requirements, the Top-Up Option is exercisable by St. Jude Medical if, following completion of the Offer, St. Jude Medical or Asteroid beneficially own at least 75% of the outstanding shares of AGA common stock. The consideration payable by St. Jude Medical upon exercise of the Top-Up Option will have a value equal to the Cash Consideration, payable in cash to the extent of the par value of shares of AGA common stock so purchased, and, as to the balance for the shares of AGA common stock so purchased, payable in cash, shares of St. Jude Medical common stock (valued at the Average Trading Price), a promissory note (bearing interest at the prime rate and with a one-year maturity date), or a combination of the foregoing. If the Top-Up Option is exercised, St. Jude Medical and Asteroid must undertake to consummate as promptly as practicable the Merger described below to acquire all remaining shares of AGA common stock not acquired in the Offer. The Top-Up Option terminates concurrently with any termination of the Merger Agreement. Any dilutive impact on the value of shares of AGA common stock as a result of the existence or exercise of the Top-Up Option, the issuance of shares of AGA common stock in the Top-Up Option or the payment for such shares with a promissory note or shares of St. Jude Medical common stock will not be taken into account in determining the fair value of any shares of AGA common stock for which appraisal rights have been properly asserted.

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Approval of the Merger (Page 75)

        If, after completion of the Offer, as it may be extended, or any exercise by Asteroid of the Top-Up Option, St. Jude Medical owns 90% or more of the outstanding shares of AGA common stock, the Merger can be accomplished without a vote of AGA stockholders. If, on the other hand, after completion of the Offer, as it may be extended, or any such exercise by St. Jude Medical of the Top-Up Option, St. Jude Medical owns more than 50% but less than 90% of the outstanding shares of AGA common stock, a special meeting of AGA stockholders and the affirmative vote at such meeting of at least a majority of the shares of AGA common stock outstanding on the record date for such meeting will be needed to complete the Merger. Because St. Jude Medical will own a majority of the shares of AGA common stock outstanding on the record date for the special meeting, approval of the Merger by AGA stockholders will be assured.

Interests of Certain Persons (Page 75)

        When you consider the recommendation of AGA's board of directors that AGA stockholders tender their shares in the Offer, you should be aware that some AGA officers and directors may have interests in the transaction that are different from, or in addition to, yours. These interests are described more fully in the section entitled "The Transaction—Interests of Certain Persons."

Certain Legal Matters; Regulatory Approval (Page 80)

        Under the HSR Act, the Merger may not be consummated unless certain filings have been submitted to the Federal Trade Commission (the "FTC") and the Antitrust Division of the U.S. Department of Justice (the "Antitrust Division"), and certain waiting period requirements have been satisfied. St. Jude Medical and AGA have filed notification and report forms under the HSR Act with the FTC and with the Antitrust Division. St. Jude Medical and AGA will also make such foreign antitrust filings as they determine are necessary.

        Notwithstanding the termination of the waiting period under the HSR Act, the FTC or the Antitrust Division could take any action under the antitrust laws as it deems necessary in the public interest. In addition, certain private parties as well as state attorneys general and other antitrust authorities could challenge the transaction under antitrust laws in certain circumstances. Foreign antitrust authorities could also take action under their antitrust laws.

Source and Amount of Funds (Page 95)

        The Offer and Merger are not conditioned upon any financing arrangements or contingencies. The amount of cash required to fund the Cash Consideration and to fund transaction-related fees and expenses will be approximately $578 million. St. Jude Medical has sufficient cash on hand to pay such consideration, if necessary.

Appraisal Rights (Page 96)

        AGA stockholders are not entitled to appraisal rights in connection with the Offer. However, the Merger will entitle AGA stockholders to appraisal rights under Section 262 of the General Corporation Law of the State of Delaware (the "DGCL"). To exercise appraisal rights, an AGA stockholder must not tender his or her shares in the Offer, must not submit a letter of election and transmittal in connection with the Offer or a letter of transmittal in connection with the Merger and must not vote in favor of (or consent to) the Merger and must strictly comply with all of the procedures required by the DGCL. These procedures are described more fully in the section entitled "The Transaction—Appraisal Rights."

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        You are urged to read the appraisal rights provisions of the DGCL, which are attached as Annex D to this prospectus/offer to exchange.

Ownership of St. Jude Medical After the Offer and Merger (Page 95)

        Based on certain assumptions regarding the number of AGA shares to be exchanged, St. Jude Medical estimates that, if all shares of AGA common stock are exchanged pursuant to the Offer and the Merger, former AGA stockholders would own, in the aggregate, approximately 3.83% of the outstanding shares of St. Jude Medical common stock. For a detailed discussion of the assumptions on which this estimate is based, please see the section of this prospectus/offer to exchange entitled "The Transaction—Ownership of St. Jude Medical After the Offer and Merger."

Comparison of St. Jude Medical Shareholder Rights and AGA Stockholder Rights (Page 210)

        After the Offer and the Merger, AGA stockholders who receive Stock Consideration in the Offer and Merger will become St. Jude Medical shareholders and their rights as shareholders will be governed by the articles of incorporation and bylaws of St. Jude Medical. There are a number of differences between the articles of incorporation and bylaws of St. Jude Medical, a Minnesota corporation, and the certificate of incorporation and bylaws of AGA, a Delaware corporation, and there are a number of differences between the applicable Minnesota and Delaware corporation statutes. These differences are discussed under the section entitled "Comparison of St. Jude Medical Shareholder Rights and AGA Stockholder Rights."

Material U.S. Federal Income Tax Consequences (Page 216)

        Provided the Offer, the Merger and the second merger, taken together, qualify as a reorganization within the meaning of Section 368(a) of the Internal Revenue Code, the tax consequences to AGA stockholders who receive shares of St. Jude Medical common stock and/or cash in exchange for AGA shares will generally be as follows:

•

an AGA stockholder who exchanges all of its AGA shares for shares of St. Jude Medical common stock in the Offer or the Merger will not recognize any gain or loss from the exchange, except with respect to cash proceeds received upon the sale of a fractional share of St. Jude Medical common stock, if any;



•

an AGA stockholder who exchanges all of its AGA shares for cash in the Offer or Merger generally will recognize gain or loss in the exchange equal to the difference between the aggregate amount of cash received for the AGA shares and the stockholder's tax basis in those AGA shares; and



•

an AGA stockholder who exchanges its AGA shares for both shares of St. Jude Medical common stock and cash in the Offer or the Merger will recognize gain, but not loss in the exchange, equal to the lesser of (a) the amount of cash received in the transaction (other than cash attributable to proceeds from the sale of a fractional share of St. Jude Medical common stock) and (b) the amount of gain realized in the transaction. The amount of gain that is realized will equal the excess of (i) the sum of the cash plus the fair market value of the St. Jude Medical common stock received over (ii) the tax basis of the AGA shares surrendered in the transaction. These AGA stockholders will also recognize gain or loss with respect to the sale of any fractional share of St. Jude Medical common stock received.

         If the St. Jude Medical common stock trading price drops significantly from the Average Trading Price prior to the close of the Offer, or the second merger, or if appraisal rights are exercised, the Offer, Merger and second merger may not qualify as a reorganization within the meaning of Section 368(a) of the Internal Revenue Code. In such circumstances, based on the adjustment provisions in the Merger Agreement, more

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AGA shares will be converted into a right to receive St. Jude Medical common stock in the Merger so that the aggregate value of the St. Jude Medical common stock issued in the transaction constitutes at least 40% of the total consideration in the Offer and the Merger. If it is not possible to increase the aggregate value of the St. Jude Medical common stock issued in the transaction to this level, the transaction will be treated as a taxable transaction for U.S. federal income tax purposes, and no proration will be made to bring the aggregate value of the St. Jude Medical common stock issued in the transaction to 40%. If necessary in order to confirm calculations relating to the impact of potential exercise of appraisal rights under Delaware law on the qualification of the Offer, the Merger and the second merger as a reorganization within the meaning of Section 368(a) of the Internal Revenue Code, AGA stockholders who exchange their shares in the Merger may not receive their merger consideration until approximately 20 days after the date of mailing of the notice of appraisal rights in connection with the Merger.

Accounting Treatment (Page 96)

        In accordance with accounting principles generally accepted in the United States, St. Jude Medical will account for the acquisition of shares of AGA common stock in the transaction under the acquisition method of accounting for business combinations.

Share Information and Market Prices for St. Jude Medical Common Stock

        St. Jude Medical common stock is traded on the New York Stock Exchange under the symbol STJ. AGA common stock is traded on the NASDAQ Global Select Market under the symbol AGAM.

        The following table lists the closing price and Average Trading Price of St. Jude Medical common stock, the closing price of AGA common stock, and the equivalent value of a share of AGA common stock if a cash election or stock election is made assuming that there was no oversubscription for the cash or stock consideration and that the final expiration date is on:

•

October 15, 2010, the trading day before the transaction was announced; and



•

October 19, 2010, the last day before commencement of the Offer.

        The "equivalent per share value of AGA common stock" on each of these two days represents the total dollar value of the consideration that an AGA stockholder would have received for one share of AGA common stock if the stockholder had made a cash election or a stock election assuming that there was no oversubscription for the cash or stock consideration and that the final expiration date had been on those dates. The total dollar value of the per share stock consideration for the Offer will be determined based on the Average Trading Price of St. Jude Medical common stock during the ten trading days prior to and including the second trading day prior to the final expiration date of the Offer. As of October 15, 2010, the Average Trading Price of St. Jude Medical common stock for the ten trading days ending on and including the second trading day before the date of determination was $39.54 and as of October 19, 2010, the Average Trading Price for the ten trading days ending on and including the second trading day before such date of determination, St. Jude Medical common stock was $39.63. For each of these two days, the total dollar value of the per share consideration for a cash election was calculated as $20.80 and for a stock election by dividing $20.80 by the Average Trading Price of St. Jude Medical common stock on each date, and then multiplying such fraction by the closing price of St. Jude Medical common stock on each date.

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        The market price of St. Jude Medical common stock may change at any time. Consequently, the total dollar value of the St. Jude Medical common stock that you will be entitled to receive, if any, as a result of the Offer or the Merger may be significantly higher or lower than its current value.

Price Range of Common Stock and Dividends

St. Jude Medical Share Prices and Dividends

        St. Jude Medical common stock is traded on the New York Stock Exchange under the symbol STJ. The following table sets forth, for the periods indicated, the high and low reported closing sale prices per share of St. Jude Medical common stock on the New York Stock Exchange composite transactions reporting system. St. Jude Medical did not declare any dividends on its common stock during the periods shown.

        On October 15, 2010 the trading day before the public announcement of the Offer and the Merger, the last sale price per share of St. Jude Medical common stock as reported on the New York Stock Exchange was $39.90. On November 12, 2010, the most recent practicable date prior to this prospectus/offer to exchange, the last sale price per share of St. Jude Medical common stock as reported on the New York Stock Exchange was $38.66.

AGA Share Prices and Dividends

        AGA common stock is traded on the NASDAQ Global Select Market under the symbol AGAM. The following table sets forth the high and low reported sale prices per share of AGA common stock for the periods indicated as quoted on the NASDAQ Global Select Market. AGA common stock began

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trading on the NASDAQ Global Select Market on October 21, 2009. AGA did not declare any cash dividends on its common stock during the periods shown.

        On October 15, 2010 the trading day before the public announcement of the Offer and the Merger, the last sale price per share of AGA common stock as reported on the NASDAQ Global Select Market was $14.71. On November 12, 2010, the most recent practicable date prior to this prospectus/offer to exchange, the last sale price per share of AGA common stock as reported on the NASDAQ Global Select Market was $20.74.

        The timing and amount of future dividends paid by St. Jude Medical and AGA are subject to determination by the applicable board of directors in their discretion and will depend upon earnings, cash requirements and the financial condition of the respective companies and their subsidiaries, and other factors deemed relevant by the applicable company's board of directors. Pursuant to the Merger Agreement, AGA and St. Jude Medical have agreed not to declare or pay any dividends with respect to their common stock, except that St. Jude Medical and AGA may declare and pay ordinary course dividends payable by a subsidiary of St. Jude Medical or AGA, respectively, to St. Jude Medical or AGA, respectively, or to another of their respective subsidiaries. See "The Merger Agreement—Other Terms of the Merger Agreement—Conduct of Business" on page 110.

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SELECTED CONSOLIDATED FINANCIAL DATA OF ST. JUDE MEDICAL

        The selected annual historical financial data presented below as of and for fiscal 2009-2005 have been derived from the audited consolidated financial statements of St. Jude Medical. The selected historical financial data for the first six months of fiscal 2010 and 2009 have been derived from the unaudited consolidated financial statements of St. Jude Medical. The unaudited financial statements for the first six months of 2010 and 2009 include all adjustments, consisting of normal recurring adjustments, which St. Jude Medical considers necessary to present a fair statement of the consolidated results of operations and financial position for the period. You should read this information in conjunction with the historical financial statements, related notes and other financial information of St. Jude Medical that are incorporated by reference into this prospectus/offer to exchange.

(in thousands except per share and ratio amounts)

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SELECTED CONSOLIDATED FINANCIAL DATA OF AGA

        The summary below sets forth historical financial data for AGA. AGA derived the selected statements of operations data for the years ended December 31, 2007, 2008 and 2009 and balance sheet data as of December 31, 2008 and 2009 from AGA's audited consolidated financial statements and related notes that are included elsewhere in this prospectus/offer to exchange. AGA derived the selected consolidated statements of operations data for the period from January 1, 2005 to July 27, 2005, the period from July 28, 2005 to December 31, 2005 and the year ended December 31, 2006 and the balance sheet data as of December 31, 2005, 2006 and 2007 from AGA's audited consolidated financial statements that do not appear in this prospectus/offer to exchange. AGA derived the consolidated statements of operations data for the six months ended June 30, 2009 and 2010 and the balance sheet data as of June 30, 2009 and 2010 from AGA's unaudited consolidated financial statements and related notes that are included elsewhere in this prospectus/offer to exchange. AGA has prepared this unaudited information on the same basis as the audited consolidated financial statements and has included all adjustments, consisting only of normal recurring adjustments, that AGA considers necessary for a fair presentation of AGA's financial position and operating results for such period. AGA has prepared the unaudited interim consolidated financial statements in accordance with accounting principles generally accepted in the United States of America, or GAAP, and the rules and regulations of the SEC for interim financial statements. AGA's historical results are not necessarily indicative of the results that may be expected in the future and the results for the six months ended June 30, 2010 are not necessarily indicative of the results for the full year. You should read this data together with AGA's consolidated financial statements and related notes included elsewhere in this prospectus/offer to exchange and the information under "AGA's Management's Discussion and Analysis of Financial Condition and Results of Operations."

        On July 28, 2005, the stockholders of AGA Medical Corporation contributed all of the outstanding shares of AGA Medical Corporation to AGA in exchange for shares of AGA. As a result of the contribution, AGA Medical Corporation became a wholly-owned subsidiary of AGA. All periods prior to July 28, 2005 are referred to as "Predecessor," and all periods on or after such date are referred to as "Successor." The data for Predecessor periods represents consolidated financial information of AGA Medical Corporation and its consolidated subsidiaries and the selected financial information for all Successor periods represents financial information of AGA and its consolidated subsidiaries. The financial statements for all Successor periods are not comparable to those of Predecessor periods.

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        Presentation for Successor periods gives effect to the 1.00 for 7.15 reverse stock split of AGA's common stock that occurred immediately prior to AGA's initial public offering.

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COMPARISON OF UNAUDITED PRO FORMA COMBINED FINANCIAL DATA AND
PER SHARE DATA

        The following tables present certain historical financial data regarding net sales, gross profit, net income (loss), book value, noncurrent assets, noncurrent liabilities and ratio of earnings to fixed charges for each of St. Jude Medical and AGA and unaudited pro forma combined financial data that give effect to the proposed Offer and Merger as a purchase of AGA by St. Jude Medical. The pro forma data of the combined company assumes a 100% acquisition of AGA common stock and the equivalent pro forma per share data for AGA assumes that 0.525 of a share of St. Jude Medical common stock will be issued in exchange for one share of AGA common stock. Please note that the actual final exchange rate will differ from this example calculation. These data have been derived from and should be read in conjunction with the selected historical consolidated financial data of St. Jude Medical and AGA included elsewhere in this prospectus/offer to exchange, and the historical consolidated financial statements of St. Jude Medical and accompanying notes thereto that are incorporated by reference into this prospectus/offer to exchange, and the historical consolidated financial statements of AGA and accompanying notes thereto that are included in this prospectus/offer to exchange. Neither St. Jude Medical nor AGA has declared or paid cash dividends on its common stock during the periods shown.

        The unaudited pro forma combined financial data and per share data is presented for informational purposes only and is based on the historical consolidated financial statements of St. Jude Medical and AGA and certain assumptions and adjustments related to a preliminary allocation of the purchase price to the net assets acquired based upon preliminary estimates of fair value. Actual amounts from the final purchase price allocation, determined on the basis of more detailed information, will differ from the amounts reflected below. You should not rely on this pro forma combined data as being indicative of the consolidated results of operations or financial condition of St. Jude Medical that would have been reported had the Merger been completed as of the dates presented, and you should not regard this data as representative of future consolidated results of operations or financial condition of St. Jude Medical. It has been assumed for the purposes of the pro forma financial information as of and for the year ended January 2, 2010 provided below that the Merger was completed on January 4, 2009, for net sales, gross profit, net income per share and ratio of earnings to fixed charges purposes and on January 2, 2010 for noncurrent assets, noncurrent liabilities and book value per share purposes. It has been assumed for purposes of the pro forma financial information as of and for the six months ended July 3, 2010 provided below that the Merger was completed on January 3, 2010, for net sales, gross profit, net income per share and ratio of earnings to

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fixed charges purposes and on July 3, 2010 for noncurrent assets, noncurrent liabilities and book value per share purposes.

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RISK FACTORS

         In considering whether to tender your shares of AGA common stock pursuant to the Offer, you should carefully consider the information in this prospectus/offer to exchange, including, in particular, the following risk factors.

Risks Relating to the Offer

The market price of St. Jude Medical common stock may decline as a result of its acquisition of AGA.

        The market price of St. Jude Medical common stock may decline after the transaction is completed if:

•

the integration of AGA's business with St. Jude Medical is unsuccessful or takes longer or is more disruptive than anticipated;



•

St. Jude Medical does not achieve the expected synergies or other benefits of the AGA acquisition as rapidly or to the extent anticipated, if at all;



•

the effect of St. Jude Medical's acquisition of AGA on its financial results does not meet St. Jude Medical's expectations or those of St. Jude Medical's financial analysts or investors; or



•

after St. Jude Medical acquires AGA, AGA's business does not perform as anticipated.

        As of October 13, 2010, there were 329,006,642 shares of St. Jude Medical common stock outstanding and 47,520,034 shares were reserved for issuance pursuant to various equity compensation plans, of which 31,832,183 shares were subject to outstanding options or other rights. In connection with the transaction, St. Jude Medical estimates that it could issue up to 13.2 million additional shares of St. Jude Medical common stock based on the shares outstanding as of October 13, 2010 and the Average Trading Price calculated as of October 19, 2010. The increase in the number of outstanding shares of St. Jude Medical common stock may lead to sales of such shares or the perception that such sales may occur, either of which may adversely affect the market price of St. Jude Medical's common stock.

The failure to complete the transaction could negatively impact the stock prices and future business and financial results of St. Jude Medical and AGA.

        If the transaction is not completed, the ongoing businesses of St. Jude Medical and AGA may be adversely affected and St. Jude Medical and AGA may be subject to several risks and consequences, including the following:

•

AGA may be required, under certain circumstances, to pay St. Jude Medical a termination fee under the Merger Agreement of $32,475,000 (or, in certain circumstances, $21,650,000);



•

St. Jude Medical and AGA are required to pay costs relating to the transaction, whether or not the transaction is completed, such as legal, accounting and printing fees;



•

under the Merger Agreement, St. Jude Medical and AGA are subject to certain restrictions on the conduct of their businesses prior to completing the transaction, which may adversely affect their ability to execute certain of their business strategies; and



•

matters relating to the transaction may require substantial commitments of time and resources by St. Jude Medical and AGA management, which would otherwise have been devoted to other opportunities that may have been beneficial to St. Jude Medical and AGA as independent companies.

        In addition, if the transaction is not completed, St. Jude Medical and AGA may experience negative reactions from the financial markets and from their respective clients and employees. St. Jude

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Medical and AGA also could be subject to litigation related to any failure to complete the transaction or to enforcement proceedings commenced against St. Jude Medical or AGA to perform their respective obligations under the Merger Agreement. If the transaction is not completed, St. Jude Medical and AGA cannot be certain that the risks described above will not materialize and will not materially affect the business, financial operations and stock prices of St. Jude Medical and AGA.

The Merger Agreement limits AGA's ability to pursue alternative transactions, and in certain instances requires payment of a termination fee, which could deter a third party from proposing an alternative transaction.

        The Merger Agreement has terms and conditions that make it difficult for AGA to enter into an alternative transaction. These "no shop" provisions impose restrictions on AGA and, subject to limited exceptions, limit AGA's ability to discuss, facilitate or commit to an alternative transaction. See "The Merger Agreement—Other Terms of the Merger Agreement—No Solicitation of Transactions" beginning on page 113 of this prospectus/offer to exchange. In addition, under specified circumstances, AGA is required to pay a termination fee as described above if the Merger Agreement is terminated. See "The Merger Agreement—Termination of the Merger Agreement—Termination Fees and Expenses" beginning on page 121 of this prospectus/offer to exchange.

        These provisions might discourage a potential competing acquiror that might have an interest in acquiring all or a significant part of AGA from considering or proposing an acquisition, even if it were prepared to pay consideration with a higher per share price than that proposed in the Offer, or might result in a potential competing acquiror proposing to pay a lower per share price to acquire AGA than it might otherwise have proposed to pay.

Even if the Offer is completed, full integration of AGA's operations with St. Jude Medical may be delayed if St. Jude Medical does not acquire at least 90% of the issued and outstanding AGA shares pursuant to the Offer.

        The Offer is subject to a condition that, before the expiration date, there shall have been validly tendered and not properly withdrawn at least a majority of AGA's shares of common stock on a fully diluted basis. If St. Jude Medical acquires at least 90% of the issued and outstanding shares of AGA common stock, the Merger will be able to be effected as a "short-form" merger under Delaware law. A short-form merger would enable St. Jude Medical to complete the acquisition of AGA without any action on the part of the other holders of AGA's common stock. If St. Jude Medical does not acquire 90% of the issued and outstanding shares of AGA's common stock in the Offer or upon exercise of the Top-Up Option, St. Jude Medical will be required to obtain the approval of AGA stockholders to consummate the Merger. Although this will not prevent the Merger from occurring, as St. Jude Medical will hold a sufficient number of shares of AGA common stock to approve the Merger, it would delay St. Jude Medical from completing the Merger and could delay the realization of some or all of the anticipated benefits from integrating AGA's operations with its operations.

AGA stockholders who receive St. Jude Medical common stock in the Offer or the Merger will become shareholders of St. Jude Medical. St. Jude Medical's common stock may be affected by different factors and holders will have different rights than those as AGA stockholders.

        Upon completion of the transaction, AGA stockholders receiving shares of St. Jude Medical common stock will become shareholders of St. Jude Medical. St. Jude Medical's business differs from that of AGA, and its results of operations and the trading price of St. Jude Medical common stock may be adversely affected by factors different from those that would affect AGA's results of operations and stock price. In addition, holders of shares of St. Jude Medical common stock will have different rights as shareholders of a Minnesota corporation than those rights they had as stockholders of a Delaware corporation before the transaction. For a detailed comparison of the rights of St. Jude Medical

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shareholders compared to the rights of AGA stockholders, see "Comparison of St. Jude Medical Shareholder Rights and AGA Stockholder Rights" beginning on page 210.

        After the effective time of the Merger, AGA stockholders will own in the aggregate a significantly smaller percentage of St. Jude Medical than they currently own of AGA. Following completion of the merger, AGA stockholders are expected to own less than 4% of the outstanding shares of St. Jude Medical common stock based on the number of shares of AGA common stock and St. Jude Medical common stock outstanding on the record date. Consequently, AGA stockholders, as a general matter, will have less influence over the management and policies of St. Jude Medical than they currently exercise over the management and policies of AGA.

AGA stockholders may not receive all consideration in the form elected.

        At the time AGA stockholders tender their shares of AGA common stock in the Offer and make an election, they will not know exactly what form of consideration they will receive because it will also depend upon the elections made by other tendering AGA stockholders. Each tendering AGA stockholder will receive either cash, shares of St. Jude Medical common stock, or a combination of cash and shares of St. Jude Medical common stock, based upon such stockholder's election (or lack thereof) and the elections of other tendering stockholders. To the extent that the demand for either Cash Consideration or Stock Consideration exceeds the aggregate amount of cash or St. Jude Medical common stock available in the Offer, St. Jude Medical will prorate the total cash or stock, as the case may be, proportionally among the AGA stockholders who elect the form of consideration for which elections exceed availability.

Required regulatory approvals may not be obtained on a timely basis or at all, which could delay or prevent completion of the transaction.

        The transaction is subject to antitrust laws. Completion of the transaction is conditioned upon the applicable waiting period having expired under the HSR Act and applicable foreign antitrust regulations. The requirement that this approval be obtained could delay the completion of the transaction for a significant period of time. St. Jude Medical filed a notification and report form under the HSR Act with the FTC and the Antitrust Division on October 18, 2010, AGA filed a notification and report form under the HSR Act with the FTC and the Antitrust Division on October 19, 2010, and the waiting period under the HSR Act will expire on November 17, 2010, unless the FTC or the Antitrust Division requests additional information. At any time before the effective time of the Merger, the Antitrust Division, the FTC or others could take action under the antitrust laws with respect to the Merger including seeking to enjoin the consummation of the Merger, to rescind the Merger or to require the divestiture of certain assets of St. Jude Medical or AGA. There can be no assurance that a challenge to the Merger on antitrust grounds will not be made or, if such a challenge is made, that it would not be successful.

AGA's executive officers and directors have financial interests in the transaction that may be different from, or in addition to, the interest of AGA stockholders.

        Executive officers of AGA negotiated the Offer and the terms of the Merger Agreement with their counterparts at St. Jude Medical, and the board of directors of AGA approved the Merger Agreement and recommended that AGA stockholders tender their shares of AGA common stock in the Offer. In considering these facts and the other information contained herein, AGA stockholders should be aware that some of AGA's executive officers and directors have financial interests in the transaction that may be different from, or in addition to, the interest of AGA stockholders. These differences include, among others, the executive officers' interests stemming from severance benefits. For a detailed discussion of the special interests that AGA's executive officers and directors may have in the transaction, please see "The Transaction—Interests of Certain Persons" beginning on page 75.

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The receipt of shares of St. Jude Medical common stock in the Offer and/or the Merger may be taxable to AGA stockholders.

        If the Offer, the Merger and the second merger are not, taken together, treated as a reorganization within the meaning of Section 368(a) of the Internal Revenue Code, the exchange of AGA shares for shares of St. Jude Medical common stock in the Offer and/or the Merger will be taxable to such stockholders for U.S. federal income tax purposes. Counsel to St. Jude Medical and AGA are expected to render opinions at the closing of the Merger that the Offer, the Merger and the second merger, taken together, will be treated as an integrated transaction that qualifies as a tax-free reorganization under Section 368(a) of the Internal Revenue Code provided other conditions are satisfied. Whether such counsel will render these opinions depends on a number of factors that will not be definitively known prior to completion of the Offer and the Merger. In addition, opinions of legal counsel are not binding on the Internal Revenue Service and there can be no assurance that the Internal Revenue Service will not challenge the conclusion set forth in counsels' opinions. Further, if the closing price of St. Jude Medical common stock falls precipitously prior to the closing of the Offer or the second merger, or if appraisal rights are exercised, there are circumstances where the Offer, the Merger and the second merger, taken together, may not qualify as a reorganization under section 368(a) of the Internal Revenue Code. The Merger Agreement contains adjustment provisions that can increase the value of the St. Jude Medical common stock issued pursuant to the Merger Agreement in order to mitigate against such risk. However, the aggregate value of the additional St. Jude Medical common stock issued pursuant to these adjustment provisions may not be sufficient for the Offer, the Merger and the second merger, taken together, to qualify as a reorganization within the meaning of Section 368(a) of the Internal Revenue Code. If the Offer, the Merger and the second merger do not, taken together, qualify as a reorganization under Section 368(a) of the Internal Revenue Code, the second merger will not occur and the Offer and Merger will be treated as a taxable sale of AGA common stock in exchange for cash and/or St. Jude Medical common stock. If that occurs, the AGA stockholders will be required to recognize gain or loss based on the value of both Cash Consideration and Stock Consideration received in the Offer and Merger, and depending on a particular stockholder's stock or cash elections and the operation of the proration mechanisms, the related tax liability may exceed the cash received in the transaction. See "Material U.S. Federal Income Tax Consequences."

        AGA stockholders should consult their tax advisors to determine the specific tax consequences to them of the Offer, the Merger and the second merger, including any federal, state, local, foreign or other tax consequences, and any tax return filing or other reporting requirements.

AGA stockholders whose shares are exchanged in the Merger have some differing considerations compared to AGA stockholders that tender in the Offer.

        The consideration payable in the Offer and the Merger will each consist of 50% of cash and 50% of shares of St. Jude Medical common stock, unless (in the case of the Merger) adjustments are required to be made in order for the Offer, the Merger and the second merger to qualify as a reorganization within the meaning of Section 368(a) of the Internal Revenue Code. However, stockholders who exchange their shares in the Merger will not have the right to elect between Cash Consideration or Stock Consideration, but instead will receive (subject to such adjustments) Cash Consideration for half of their shares of AGA common stock and Stock Consideration for half of their shares of AGA common stock. In the event that adjustments must be made pursuant to the Merger Agreement in order for the Offer, the Merger and the second merger to qualify as a reorganization within the meaning of Section 368(a) of the Internal Revenue Code, then AGA stockholders that exchange their shares in the Merger may receive Stock Consideration for more than 50% of their shares of AGA common stock and Cash Consideration for fewer than 50% of their shares of AGA common stock. If necessary in order to confirm calculations relating to the impact of potential exercise

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of appraisal rights under Delaware law on the qualification of the Offer, the Merger and the second merger as a reorganization within the meaning of Section 368(a) of the Internal Revenue Code, AGA stockholders who exchange their shares in the Merger may not receive their merger consideration until approximately 20 days after the date of mailing of the notice of appraisal rights in connection with the Merger.

While the value of the consideration AGA stockholders receive is intended to be the same whether a stockholder receives cash or St. Jude Medical common stock, the market value of St. Jude Medical common stock may change after the determination of the Average Trading Price.

        The value of the consideration AGA stockholders receive is intended to be the same whether a stockholder receives cash or St. Jude Medical common stock. This equivalence is based on the Average Trading Price. However, the market value of St. Jude Medical common stock may change after the determination of the Average Trading Price. The market value of St. Jude Medical common stock on the date the Stock Consideration is paid to an AGA stockholder in the Offer or the Merger is likely to be different than the closing stock prices set forth in this prospectus/offer to exchange.

Risks Relating to St. Jude Medical's Business

St. Jude Medical faces intense competition and may not be able to keep pace with the rapid technological changes in the medical devices industry.

        The medical device market is intensely competitive and is characterized by extensive research and development and rapid technological change. St. Jude Medical's customers consider many factors when choosing suppliers, including product reliability, clinical outcomes, product availability, inventory consignment, price and product services provided by the manufacturer, and market share can shift as a result of technological innovation and other business factors. Major shifts in industry market share have occurred in connection with product problems, physician advisories and safety alerts, reflecting the importance of product quality in the medical device industry. St. Jude Medical's competitors range from small start-up companies to larger companies which have significantly greater resources and broader product offerings than it, and it anticipates that in the coming years, other large companies will enter certain markets in which it currently hold a strong position. For example, Boston Scientific acquired one of St. Jude Medical's principal competitors, Guidant Corporation, in 2006. In addition, St. Jude Medical expects that competition will continue to intensify with the increased use of strategies such as consigned inventory, and it has seen increasing price competition as a result of managed care, consolidation among healthcare providers, increased competition and declining reimbursement rates. Product introductions or enhancements by competitors which have advanced technology, better features or lower pricing may make its products or proposed products obsolete or less competitive. As a result, it will be required to devote continued efforts and financial resources to bring St. Jude Medical's products under development to market, enhance St. Jude Medical's existing products and develop new products for the medical marketplace. If it fails to develop new products, enhance existing products or compete effectively, St. Jude Medical's business, financial condition and results of operations will be adversely affected.

St. Jude Medical is subject to stringent domestic and foreign medical device regulation and any adverse regulatory action may materially adversely affect St. Jude Medical's financial condition and business operations.

        St. Jude Medical's products, development activities and manufacturing processes are subject to extensive and rigorous regulation by numerous government agencies, including the FDA and comparable foreign agencies. To varying degrees, each of these agencies monitors and enforces St. Jude Medical's compliance with laws and regulations governing the development, testing, manufacturing, labeling, marketing and distribution of its medical devices. The process of obtaining marketing approval

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or clearance from the FDA and comparable foreign bodies for new products, or for enhancements or modifications to existing products, could:

•

take a significant amount of time;



•

require the expenditure of substantial resources;



•

involve rigorous pre-clinical and clinical testing, as well as increased post-market surveillance;



•

involve modifications, repairs or replacements of its products; and



•

result in limitations on the indicated uses of St. Jude Medical's products.

        St. Jude Medical cannot be certain that it will receive required approval or clearance from the FDA and foreign regulatory agencies for new products or modifications to existing products on a timely basis. The failure to receive approval or clearance for significant new products or modifications to existing products on a timely basis could have a material adverse effect on its financial condition and results of operations.

        Both before and after a product is commercially released, St. Jude Medical has ongoing responsibilities under FDA regulations. For example, it is required to comply with the FDA's Quality System Regulation (QSR), which mandates that manufacturers of medical devices adhere to certain quality assurance requirements pertaining to, among other things, validation of manufacturing processes, controls for purchasing product components, and documentation practices. As another example, the Federal Medical Device Reporting regulation requires it to provide information to the FDA whenever there is evidence that reasonably suggests that a device may have caused or contributed to a death or serious injury or, that a malfunction occurred which would be likely to cause or contribute to a death or serious injury upon recurrence. Compliance with applicable regulatory requirements is subject to continual review and is monitored rigorously through periodic inspections by the FDA, which may result in observations on Form 483, and in some cases warning letters, that require corrective action. If the FDA were to conclude that it is not in compliance with applicable laws or regulations, or that any of St. Jude Medical's medical devices are ineffective or pose an unreasonable health risk, the FDA could ban such medical devices, detain or seize such medical devices, order a recall, repair, replacement, or refund of such devices, or require it to notify health professionals and others that the devices present unreasonable risks of substantial harm to the public health. The FDA has recently been increasing its scrutiny of the medical device industry and the government should be expected to continue to scrutinize the industry closely with inspections, and possibly enforcement actions, by the FDA or other agencies. Additionally, the FDA may restrict manufacturing and impose other operating restrictions, enjoin and restrain certain violations of applicable law pertaining to medical devices, and assess civil or criminal penalties against St. Jude Medical, its officers or its employees. The FDA may also recommend prosecution to the Department of Justice. Any adverse regulatory action, depending on its magnitude, may restrict it from effectively manufacturing, marketing and selling St. Jude Medical's products. In addition, negative publicity and product liability claims resulting from any adverse regulatory action could have a material adverse effect on St. Jude Medical's financial condition and results of operations.

        Foreign governmental regulations have become increasingly stringent and more common, and it may become subject to even more rigorous regulation by foreign governmental authorities in the future. Penalties for a company's noncompliance with foreign governmental regulation could be severe, including revocation or suspension of a company's business license and criminal sanctions. Any domestic or foreign governmental medical device law or regulation imposed in the future may have a material adverse effect on St. Jude Medical's financial condition and business operations.

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St. Jude Medical's products are continually the subject of clinical trials conducted by it, its competitors or other third parties, the results of which may be unfavorable, or perceived as unfavorable by the market, and could have a material adverse effect on St. Jude Medical's business, financial condition or results of operations.

        As a part of the regulatory process of obtaining marketing clearance for new products and new indications for existing products, it conducts and participates in numerous clinical trials with a variety of study designs, patient populations and trial endpoints. Unfavorable or inconsistent clinical data from existing or future clinical trials conducted by it, by St. Jude Medical's competitors or by third parties, or the market's or FDA's perception of this clinical data, may adversely impact St. Jude Medical's ability to obtain product approvals, St. Jude Medical's position in, and share of, the markets in which it participates and its business, financial condition, results of operations or future prospects.

If St. Jude Medical is unable to protect its intellectual property effectively, its financial condition and results of operations could be adversely affected.

        Patents and other proprietary rights are essential to St. Jude Medical's business and its ability to compete effectively with other companies is dependent upon the proprietary nature of its technologies. It also relies upon trade secrets, know-how, continuing technological innovations and licensing opportunities to develop, maintain and strengthen its competitive position. It seeks to protect these, in part, through confidentiality agreements with certain employees, consultants and other parties. It pursues a policy of generally obtaining patent protection in both the United States and in key foreign countries for patentable subject matter in its proprietary devices and also attempts to review third-party patents and patent applications to the extent publicly available to develop an effective patent strategy, avoid infringement of third-party patents, identify licensing opportunities and monitor the patent claims of others. It currently owns numerous United States and foreign patents and has numerous patent applications pending. It is also a party to various license agreements pursuant to which patent rights have been obtained or granted in consideration for cash, cross-licensing rights or royalty payments. It cannot be certain that any pending or future patent applications will result in issued patents, that any current or future patents issued to it or licensed by it will not be challenged, invalidated or circumvented or that the rights granted thereunder will provide a competitive advantage to it or prevent competitors from entering markets which it currently serves. Any required license may not be available to it on acceptable terms, if at all. In addition, some licenses may be non-exclusive, and therefore its competitors may have access to the same technologies as it. In addition, it may have to take legal action in the future to protect its trade secrets or know-how or to defend them against claimed infringement of the rights of others. Any legal action of that type could be costly and time consuming and St. Jude Medical cannot be certain of the outcome. The invalidation of key patents or proprietary rights which it owns or an unsuccessful outcome in lawsuits to protect its intellectual property could have a material adverse effect on its financial condition and results of operations.

Pending and future patent litigation could be costly and disruptive to St. Jude Medical and may have an adverse effect on its financial condition and results of operations.

        St. Jude Medical operates in an industry that is susceptible to significant patent litigation and, in recent years, it has been common for companies in the medical device field to aggressively challenge the rights of other companies to prevent the marketing of new devices. Companies that obtain patents for products or processes that are necessary for or useful to the development of its products may bring legal actions against it claiming infringement and at any given time, it generally is involved as both a plaintiff and a defendant in a number of patent infringement and other intellectual property-related actions. Defending intellectual property litigation is expensive and complex and outcomes are difficult to predict. Any pending or future patent litigation may result in significant royalty or other payments or injunctions that can prevent the sale of products and may cause a significant diversion of the efforts of its technical and management personnel. While it intends to defend any such lawsuits vigorously, it

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cannot be certain that it will be successful. In the event that its right to market any of its products is successfully challenged or if it fails to obtain a required license or is unable to design around a patent, its financial condition and results of operations could be materially adversely affected.

Pending and future product liability claims and litigation may adversely affect St. Jude Medical's financial condition and results of operations.

        The design, manufacture and marketing of the medical devices it produces entail an inherent risk of product liability claims. Its products are often used in intensive care settings with seriously ill patients, and many of the medical devices it manufactures and sells are designed to be implanted in the human body for long periods of time or indefinitely. There are a number of factors that could result in an unsafe condition or injury to, or death of, a patient with respect to these or other products which it manufactures or sells, including component failures, manufacturing flaws, design defects or inadequate disclosure of product-related risks or product-related information. Product liability claims may be brought by individuals or by groups seeking to represent a class.

        St. Jude Medical is currently the subject of various product liability claims, including several lawsuits in the United States and a lawsuit being allowed to proceed as a class action in Canada relating to products incorporating Silzone® coating. The outcome of litigation, particularly class action lawsuits, is difficult to assess or quantify. Plaintiffs in these types of lawsuits often seek recovery of very large or indeterminate amounts, and the magnitude of the potential loss relating to such lawsuits may remain unknown for substantial periods of time. St. Jude Medical believes that the final resolution of the Silzone litigation matters may take a number of years and cannot reasonably estimate the time frame in which any potential settlements or judgments would be paid out or the amounts of any such settlements or judgments. In addition, the cost to defend any future litigation, whether Silzone-related or not, may be significant. It believes that many settlements and judgments relating to the Silzone litigation and its other litigation may be covered in whole or in part under its previously-issued product liability insurance policies and existing reserves. Any costs (the material components of which are settlements, judgments, legal fees and other related defense costs) not covered under its previously-issued product liability insurance policies and existing reserves could have a material adverse effect on its consolidated earnings, financial position and cash flows.

St. Jude Medical's product liability insurers may refuse to cover certain losses on the grounds that such losses are outside the scope of its product liability insurance policies.

        One of St. Jude Medical's prior product liability insurers has filed a suit seeking a court order declaring that it is not required to provide coverage for some of the costs St. Jude Medical has incurred or may incur in the future in the Silzone® litigation described above. This insurer, as well as other insurers from whom it had purchased product liability insurance, may deny coverage of these and other past and/or future losses relating to its products on the grounds that such losses are outside the scope of coverage of those previously-issued insurance policies. To the extent that it suffers losses that are outside of the scope or range of coverage of those previously-issued product liability insurance policies, those losses may have a material adverse effect on its consolidated earnings, financial position and cash flows.

St. Jude Medical's self-insurance program may not be adequate to cover future losses.

        Consistent with the predominant practice in its industry, it does not currently maintain or intend to maintain any insurance policies with respect to product liability in the future. This decision was made based on current conditions in the insurance marketplace that have led to increasingly higher levels of self-insured retentions, increasing number of coverage limitations and high insurance premium rates. It will continue to monitor the insurance marketplace to evaluate the value to it of obtaining insurance coverage in the future. It believes that its self-insurance program, which is based on historical loss

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trends, will be adequate to cover future losses, although it can provide no assurances that this will remain true as historical trends may not be indicative of future losses. These losses could have a material adverse impact on its consolidated earnings, financial condition or cash flows.

The loss of any of St. Jude Medical's sole-source suppliers or an increase in the price of inventory supplied to it could have an adverse effect on its business, financial condition and results of operations.

        St. Jude Medical purchases certain supplies used in its manufacturing processes from single sources due to quality considerations, costs or constraints resulting from regulatory requirements. Agreements with certain suppliers are terminable by either party upon short notice and it has been advised periodically by some suppliers that in an effort to reduce their potential product liability exposure, it may terminate sales of products to customers that manufacture implantable medical devices. While some of these suppliers have modified their positions and have indicated a willingness to continue to provide a product temporarily until an alternative vendor or product can be qualified (or even to reconsider the supply relationship), where a particular single-source supply relationship is terminated, it may not be able to establish additional or replacement suppliers for certain components or materials quickly. This is largely due to the FDA approval system, which mandates validation of materials prior to use in its products, and the complex nature of manufacturing processes employed by many suppliers. In addition, it may lose a sole-source supplier due to, among other things, the acquisition of such a supplier by a competitor (which may cause the supplier to stop selling its products to it) or the bankruptcy of such a supplier, which may cause the supplier to cease operations. A reduction or interruption by a sole-source supplier of the supply of materials or key components used in the manufacturing of its products or an increase in the price of those materials or components could adversely affect its business, financial condition and results of operations.

Cost containment pressures and domestic and foreign legislative or administrative reforms resulting in restrictive reimbursement practices of third-party payors or preferences for alternate therapies could decrease the demand for products purchased by St. Jude Medical's customers, the prices which they are willing to pay for those products and the number of procedures using its devices.

        St. Jude Medical's products are purchased principally by healthcare providers that typically bill various third-party payors, such as governmental programs (e.g., Medicare and Medicaid), private insurance plans and managed care plans, for the healthcare services provided to their patients. The ability of customers to obtain appropriate reimbursement for their services and the products they provide from government and third-party payors is critical to the success of medical technology companies. The availability of reimbursement affects which products customers purchase and the prices they are willing to pay. Reimbursement varies from country to country and can significantly impact the acceptance of new technology. After it develops a promising new product, it may find limited demand for the product unless reimbursement approval is obtained from private and governmental third-party payors.

        Major third-party payors for healthcare provider services in the United States and abroad continue to work to contain healthcare costs. The introduction of cost containment incentives, combined with closer scrutiny of healthcare expenditures by both private health insurers and employers, has resulted in increased discounts and contractual adjustments to healthcare provider charges for services performed and in the shifting of services between inpatient and outpatient settings. Initiatives to limit the growth of healthcare costs, including price regulation, are also underway in several countries in which it does business. Implementation of healthcare reforms in the United States and in significant overseas markets such as Germany, Japan and other countries may limit the price of, or the level at which, reimbursement is provided for its products and adversely affect both its pricing flexibility and the demand for its products. Healthcare providers may respond to such cost-containment pressures by substituting lower cost products or other therapies for its products.

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        In March 2010, significant health care reform was enacted into law in the United States, which included a number of provisions aimed at improving quality and decreasing costs. It is uncertain what consequences these provisions will have on patient access to new technologies and what impacts these provisions will have on Medicare reimbursement rates. Legislative or administrative reforms to the U.S. or international reimbursement systems that significantly reduce reimbursement for procedures using its medical devices or deny coverage for such procedures, or adverse decisions relating to its products by administrators of such systems in coverage or reimbursement issues, would have an adverse impact on the products, including clinical products, purchased by its customers and the prices its customers are willing to pay for them. This in turn would have an adverse effect on its financial condition and results of operations.

St. Jude Medical's failure to comply with restrictions relating to reimbursement and regulation of healthcare goods and services may subject it to penalties and adversely affect its financial condition and results of operations.

        St. Jude Medical's devices are subject to regulation regarding quality and cost by the United States Department of Health and Human Services, including the Centers for Medicare and Medicaid Services (CMS), as well as comparable state and foreign agencies responsible for reimbursement and regulation of healthcare goods and services. Foreign governments also impose regulations in connection with their healthcare reimbursement programs and the delivery of healthcare goods and services. U.S. federal government healthcare laws apply when it submits a claim on behalf of a U.S. federal healthcare program beneficiary, or when a customer submits a claim for an item or service that is reimbursed under a U.S. federal government funded healthcare program, such as Medicare or Medicaid. The principal U.S. federal laws implicated include those that prohibit the filing of false or improper claims for federal payment, those that prohibit unlawful inducements for the referral of business reimbursable under federally-funded healthcare programs, known as the anti-kickback laws, and those that prohibit healthcare service providers seeking reimbursement for providing certain services to a patient who was referred by a physician that has certain types of direct or indirect financial relationships with the service provider, known as the Stark law.

        The laws applicable to St. Jude Medical are subject to evolving interpretations. If a governmental authority were to conclude that it is not in compliance with applicable laws and regulations, it and its officers and employees could be subject to severe criminal and civil penalties, including, for example, exclusion from participation as a supplier of product to beneficiaries covered by CMS. If it is excluded from participation based on such an interpretation, it could adversely affect its financial condition and results of operations.

Consolidation in the healthcare industry could lead to demands for price concessions or limit or eliminate its ability to sell to certain of its significant market segments.

        The cost of healthcare has risen significantly over the past decade and numerous initiatives and reforms initiated by legislators, regulators and third-party payors to curb these costs have resulted in a consolidation trend in the medical device industry as well as among its customers, including healthcare providers. This in turn has resulted in greater pricing pressures and limitations on its ability to sell to important market segments, as group purchasing organizations, independent delivery networks and large single accounts, such as the Veterans Administration in the United States, continue to consolidate purchasing decisions for some of its healthcare provider customers. It expects that market demand, government regulation, third-party reimbursement policies and societal pressures will continue to change the worldwide healthcare industry, resulting in further business consolidations and alliances which may exert further downward pressure on the prices of its products and adversely impact its business, financial condition and results of operations.

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Failure to integrate acquired businesses into St. Jude Medical's operations successfully could adversely affect its business.

        As part of St. Jude Medical's strategy to develop and identify new products and technologies, it has made several acquisitions in recent years and may make additional acquisitions in the future. Its integration of the operations of acquired businesses requires significant efforts, including the coordination of information technologies, research and development, sales and marketing, operations, manufacturing and finance. These efforts result in additional expenses and involve significant amounts of management's time that cannot then be dedicated to other projects. Its failure to manage successfully and coordinate the growth of the combined company could also have an adverse impact on its business. In addition, it cannot be certain that the businesses it acquires will become profitable or remain so. If its acquisitions are not successful, it may record unexpected impairment charges. Factors that will affect the success of its acquisitions include:

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the presence or absence of adequate internal controls and/or significant fraud in the financial systems of acquired companies;



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adverse developments arising out of investigations by governmental entities of the business practices of acquired companies;



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any decrease in customer loyalty and product orders caused by dissatisfaction with the combined companies' product lines and sales and marketing practices, including price increases;



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its ability to retain key employees; and



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the ability of the combined company to achieve synergies among its constituent companies, such as increasing sales of the combined company's products, achieving cost savings and effectively combining technologies to develop new products.