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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 NumberS155
Date Received11/10/2021
Decision Date01/26/2022
Product Code MVK 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a minor design change to the plastic therapy electrode enclosures and the therapy electrode laminate on the LifeVest 4000 electrode belt
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