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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 NumberS015
Date Received10/30/2009
Decision Date12/16/2009
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 OF AN ALTERNATE FLASH/SRAM CHIP FOR USE ON THE WCD 3100, A CORRECTION OF A BILL OF MATERIALS ERROR ON THE WCD 3100 COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY, AND TWO DESIGN CHANGES TO THE HIGH VOLTAGE CONVERTER CIRCUIT ON THE DEFIBRILLATOR PRINTED CIRCUIT ASSEMBLY.
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