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ZOLL First Company to Receive Premarket Approval from the FDA on its Full Portfolio of Defibrillators - Medical Corporation 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 - ZOLL.com
ZOLL First Company to Receive Premarket Approval from the FDA on its Full Portfolio of Defibrillators

 

PRZOOM - /newswire/ - Chelmsford, MA, United States, 2018/01/09 - Medical Corporation 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 - ZOLL.com. NASDAQ: ZOLL

   
 
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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 (zoll.com), 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.

About Asahi Kasei

The Asahi Kasei Group (asahi-kasei.co.jp) is a diversified group of companies led by holding company Asahi Kasei Corporation, 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.

Copyright © 2018 ZOLL Medical Corporation. All rights reserved. AED Plus, AED Pro, Real CPR Help, R Series, X Series, and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.

 
 
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Agency / Source: ZOLL Medical Corporation

 
 

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ZOLL First Company to Receive Premarket Approval from the FDA on its Full Portfolio of Defibrillators

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Contact: Diane Egan - ZOLL.com 
978-421-9637 degan[.]zoll.com
 
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IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any ZOLL Medical Corporation securities in any jurisdiction including any other companies listed or named in this release.

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