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
