ZOLL First Company to Receive FDA's Premarket Approval on Defibrillators
January 9, 2018—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 which 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.”