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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 NumberS032
Date Received05/14/2012
Decision Date07/13/2012
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 2 MECHANICAL DESIGN MODIFICATIONS TO THE METHOD OF ATTACHING THE HOOK COMPONENT OF THE HOOK AND LOOP FASTENERS TO THE ECG ELECTRODE HOUSING.
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