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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.
 
DeviceLifeVest® Wearable Defibrillator
Generic NameWearable automated external defibrillator
ApplicantZOLL MANUFACTURING CORPORATION
121 GAMMA DR
PITTSBURGH, PA 15238-0000
PMA NumberP010030
Supplement NumberS153
Date Received10/01/2021
Decision Date10/12/2021
Product Code MVK 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Alternate tier II suppliers of raw material components for assembly onto the LifeVest 4000 Monitor Printed Circuit Assembly.
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