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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 Device
Generic NameWearable automated external defibrillator
ApplicantZoll Manufacturing Corporation
121 Gamma Dr.
Pittsburgh, PA 15238
PMA NumberP010030
Supplement NumberS085
Date Received10/04/2016
Decision Date11/03/2016
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  
Implementing an alternate testing method for the 4000/4000B electrode belts and re-sequencing of two existing test steps.
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