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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 NumberS059
Date Received12/22/2014
Decision Date11/06/2015
Product Code MVK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR:1) REDESIGNED ECG AND BELT NODE PCAS; 2) ADDITION OF A FERRITE BEAD TO THE TRUNK CABLE ASSEMBLY AND MODIFICATION TO THE BELT NODE PLASTIC ENCLOSURE; 3) CONNECTORIZED THERAPY ELECTRODE (TE); 4) THERAPY ELECTRODE GAS GENERATOR PLASTIC ENCLOSURE INSPECTION WINDOW; 5) ADDITION OF AN ACCELEROMETER TO THE FRONT TE AND ADDITIONAL CONDUCTORS TO THE CABLE ASSEMBLIES6) ADDITION OF THE TE ADVISORY LABELS TO THE ELECTRODE BELT.
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