Current Report Filing (8-k)
May 03 2019 - 9:28AM
Edgar (US Regulatory)
U
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IT
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IT
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TON, DC
2
0549
F
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8
-
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e
c
tion
13 or
15(d) of
t
h
e
S
ec
u
r
ities Excha
n
ge
A
c
t of
1934
Da
t
e
of
re
p
o
r
t
(
D
a
t
e
of
e
a
r
l
i
e
st
e
v
e
n
t
r
e
p
o
r
t
e
d)
:
May 2, 2019
STAAR Surgical Company
(
Ex
act
N
a
m
e
of
Re
g
i
s
trant
a
s
S
p
ecified
i
n
Charter)
|
Delaware
|
0-11634
|
95-3797439
|
|
(State or Other Jurisdiction
of Incorporation)
|
(Commission File Number)
|
(IRS Employer
Identification No.)
|
|
|
|
|
|
1911 Walker Ave.,
Monrovia, California
|
|
91016
|
|
(Address of Principal Executive Offices)
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|
(Zip Code)
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Registrant’s Telephone Number, Including Area Code:
626-303-7902
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Che
c
k
t
he a
ppropr
iate
bo
x
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ark
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ot
to
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ded
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ion
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f
or co
m
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th
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or
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t
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v
ided
p
u
r
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a
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ection
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of
t
h
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x
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h
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n
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A
ct.
☐
Item 7.01 Regulation FD Disclosure.
On May 2, 2019, the Company received a letter dated May 2, 2019 from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA). The FDA advised the Company it had completed an initial scientific review of the Company’s premarket approval application (PMA) supplement regarding EVO/EVO+ Visian Implantable Collamer Lens for Myopia and EVO/EVO+ Visian Toric Implantable Collamer Lens for Myopia with Astigmatism. The FDA advised the Company that its PMA supplement lacked information, particularly the clinical evidence and analysis, that would permit the completion of the review and determination of whether there is a reasonable assurance of the device’s safety and effectiveness for its intended use. The Company expects to continue discussions with the FDA, including discussing the FDA’s concerns with the existing PMA supplement and any new clinical data that may be required.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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STAAR Surgical Company
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May 3, 2019
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By:
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/s/ Caren Mason
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Caren Mason
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President and Chief Executive Officer
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