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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 NumberS170
Date Received11/07/2023
Decision Date02/14/2024
Product Code MVK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
labeling changes associated with 5G cellular immunity to the Instruction for Use (IFU) manuals for the LifeVest 5100 system: LifeVest 5100 Patient Manual (US English), LifeVest 5100 Patient Manual SUS (US Spanish), LifeVest 5100 Clinical Manual, and LifeVest 5100 Field Manual
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