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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 NumberS053
Date Received05/27/2014
Decision Date11/06/2015
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 FOR THE LIFEVEST WEARABLE DEFIBRILLATOR 4000 AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR. THE DEVICE AS MODIFIED IS APPROVED FOR 1) CHANGE TO THE LENGTH OF THE THERAPY ELECTRODE CHANNEL FOAM; 2) CHANGE TO THE DIMENSIONAL TOLERANCES OF THE HOLE LOCATIONS ON THE THERAPY ELECTRODELIDDING LAYER;3) CHANGE FROM ADHESIVE TO CRIMPING OF THE BATTERY CONNECTOR AND REINFORCEMENT OF THE BATTERY CELLS WITHIN THE WCD 4000 PACK; AND4) CHANGE OF MATERIAL OF THE HEX NUT USED IN THE WCD 4000 MONITOR ELECTRODE BELTRECEPTACLE FROM BRASS TO STAINLESS STEEL.
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