ZOLL first company to receive premarket approval from the FDA on its full portfolio of defibrillators
CHELMSFORD, Mass. — ZOLL® Medical Corporation, a manufacturer of medical devices and related software solutions, today announced that it is the first company to achieve premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) to continue to market and distribute its full line of defibrillators in the U.S.
The list of defibrillators that received PMA approval include the R Series® and X Series® monitor/defibrillators and the AED Pro® and AED Plus® automated external defibrillators. All of these devices are equipped with ZOLL’s proprietary Rectilinear Biphasic™ waveform to deliver maximum current to high-impedance patients and Real CPR Help® technology that helps rescuers perform high-quality CPR.
“ZOLL is very pleased to have received PMA approval for our entire portfolio of defibrillators,” said A. Ernest Whiton, President of ZOLL’s Resuscitation division. “This is the most stringent level of regulatory approval for safety and efficacy of a medical device, and represents ZOLL’s long-standing commitment to product quality, safety, and efficacy.”
About ZOLL Medical Corporation
ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. For more information, visit www.zoll.com.
About Asahi Kasei
The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit www.asahi-kasei.co.jp/asahi/en/.