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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
PMA NumberP010030
Supplement NumberS204
Date Received09/10/2026
Decision Date10/05/2026
Product Code MVK 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
removal of an inspection step performed during manufacturing and servicing
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