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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 15238-0000
PMA NumberP010030
Supplement NumberS089
Date Received12/27/2016
Decision Date01/26/2017
Product Code MVK 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of an alternate supplier (Walco Corporation; Glenshaw, PA) to provide the pre-cut Urethane Foam (.500 x .219) used to cushion the SD card in the LifeVest units.
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