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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 (WCD) 2000 LIFEVEST
Generic NameWearable automated external defibrillator
ApplicantZoll Manufacturing Corporation
121 Gamma Dr.
Pittsburgh, PA 15238
PMA NumberP010030
Supplement NumberS191
Date Received03/03/2025
Decision Date05/30/2025
Product Code MVK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for implementation of a software update to the LifeVest 5100 Monitor and Electrode Belt software to software version V0006
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