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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceWEARABLE CARDIOVERTER DEFIBRILLATOR
Classification Namewearable automated external defibrillator
Generic Namewearable automated external defibrillator
Applicant
ZOLL MANUFACTURING CORPORATION
121 gamma dr
pittsburgh, PA 15238-0000
PMA NumberP010030
Supplement NumberS038
Date Received10/22/2012
Decision Date11/20/2012
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
MODIFICATIONS TO A FIXTURE AND A CHANGE IN THE BACKUP BATTERY CHARGING PROCESS DURING THE THERMAL CYCLING.
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