Royal Philips has announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for the company’s HeartStart FR3 (Model 861388 and Model 861389) and HeartStart FRx (Model 861304) automated external defibrillators (AEDs), and their supporting accessories, including batteries and pads.
The HeartStart FR3 is a professional grade AED with advanced features to help medical personnel and first-responders treat cardiac arrest. The HeartStart FRx is a public-access AED that features intuitive, step-by-step voice instructions, including cardiopulmonary resuscitation (CPR) guidance, for emergency use in workplaces, schools and other public spaces, as well as for medical professional use.
“We are pleased to receive premarket approval for our HeartStart FR3 and HeartStart FRx AEDs,” said Arman Voskerchyan, business leader therapeutic care at Philips. “This complements the premarket approval that we received last year for our HeartStart OnSite and HeartStart Home AEDs. Our industry leading portfolio of AEDs is instrumental in helping save the lives of numerous sudden cardiac arrest victims in the U.S. and worldwide. We look forward to continuing to meet our commitment to our medical professional and public-access customers, and especially to the victims of sudden cardiac arrest who rely on our AEDs.”
FDA PMA information for the HeartStart FR3 and HeartStart FRx defibrillators can be found here and here, respectively. These devices have been marketed to date under FDA premarket notifications (510(k)), but are now approved under PMA.
In 2019, Philips received PMA approval for its HeartStart OnSite and HeartStart Home defibrillators, which are the only over-the-counter AEDs available to consumers in the U.S.