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Physio-Control Receives Premarket Approval from the FDA

Print Article Contributed by FSM Staff


REDMOND, WA -- Physio-Control, now part of Stryker, announced it has received premarket approval (PMA) by the U.S. Food and Drug Administration to continue to market and distribute its full line of LIFEPAK professional defibrillators in the U.S.

The list of professional-use defibrillators that received PMA approval include: LIFEPAK 1000 defibrillator, LIFEPAK 20 (Refurbished) defibrillator/monitor, LIFEPAK 20e defibrillator/monitor and LIFEPAK 15 monitor/defibrillator.

“Physio-Control is excited to have reached this major milestone with our complete portfolio of devices in both the professional and public safety markets,” says Anne Mullally, vice president and GM, Stryker EMS and Physio-Control. “This is the culmination of several years of significant work, substantiating the safety and effectiveness of our devices, and is the highest bar FDA Class III medical devices must meet. This represents our continued commitment to producing the most reliable, highest quality, and science-driven products that our customers need to support their patients and communities.”

In January 12, 2017 following an extensive submission, Physio-Control’s HeartSine ® business group based in Belfast, Ireland, was the first AED manufacturer to receive PMA for the three HeartSine samaritan ® models SAM 350P, SAM 360P and SAM 450P automated external defibrillators (AEDs) as well as the Pad-Pak™, Pediatric-Pak™, TSO-certified Pad-Pak and Saver EVO™ software. Physio-Control’s AEDs, LIFEPAK CR ® Plus and LIFEPAK EXPRESS, received PMA on December 21, 2017.





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