Philips receives FDA premarket approval for its HeartStart OnSite and HeartStart Home defibrillators
June 19 2019 - 9:00AM
June 19, 2019
Amsterdam, the Netherlands – Royal
Philips (NYSE: PHG, AEX: PHIA), a global leader in health
technology, today announced that the Center for Devices and
Radiological Health (CDRH) of the Food and Drug Administration
(FDA) has approved the company’s premarket approval (PMA)
application for its HeartStart OnSite defibrillator [1] and
HeartStart Home defibrillator [2], and the relevant supporting
accessories, such as batteries and pad electrodes.
Philips’ HeartStart OnSite and HeartStart Home defibrillators
are the only over-the-counter automated external defibrillators
(AEDs) available to consumers in the US, while the HeartStart Home
defibrillator is the only AED specifically indicated for home
environments.
“We are committed to delivering high quality, innovative AEDs to
provide personalized therapy to victims of sudden cardiac arrest,”
said Arman Voskerchyan, Business Leader Therapeutic Care at
Philips. “Premarket approval for our HeartStart OnSite and
HeartStart Home defibrillators, currently the only over-the-counter
AEDs available in the US, reflects the robust work of our teams
that delivered the strong and extensive technical, clinical and
production data included in the PMA filing for these devices.”
PMA for Philips’ HeartStart OnSite and HeartStart Home
defibrillators can be found here. These devices already had FDA
510(k) clearance, but are now subject to PMA.
[1] Model M5066A[2] Model M5068A
For further information, please contact:
Steve KlinkPhilips Group Press OfficeTel. +31 6
10888824E-mail: steve.klink@philips.com
Kathy O’ReillyPhilips Group Press OfficeTel.: +1 978 221
8919E-mail : kathy.oreilly@philips.comTwitter:
@kathyoreilly
About Royal PhilipsRoyal Philips (NYSE: PHG,
AEX: PHIA) is a leading health technology company focused on
improving people's health and enabling better outcomes across the
health continuum from healthy living and prevention, to diagnosis,
treatment and home care. Philips leverages advanced technology and
deep clinical and consumer insights to deliver integrated
solutions. Headquartered in the Netherlands, the company is a
leader in diagnostic imaging, image-guided therapy, patient
monitoring and health informatics, as well as in consumer health
and home care. Philips' health technology portfolio generated 2018
sales of EUR 18.1 billion and employs approximately 77,000
employees with sales and services in more than 100 countries. News
about Philips can be found at
http://www.philips.com/newscenter.
- Philips AED
- Philips AED 2
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