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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 NumberS064
Date Received07/02/2015
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 TWO ELECTRICAL DESIGN CHANGES FOR THE LIFEVEST WEARABLEDEFIBRILLATOR 4000 MONITOR PULSE DELIVERY CIRCUITRY. THESE CHANGES INCLUDE AND INCREASE THE VALUES OF FOUR DC BLOCKING CAPACITORS ON THE DEFIBRILLATOR PCA AND TWO BULK CAPACITORS ON THE MONITOR COMPUTER/ANALOG (C/A) BOARD, AS WELL AS CHANGE THE DC BLOCKING CAPACITOR DIELECTRIC FROM Y5V TO X7R AND THE ADDITION OF FERRITE BEAD TO THE BATTERY POWER WIRE ON THE C/A BOARD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WEARABLE DEFIBRILLATOR 4000 AND IS INDICATED FOR ADULT PATIENTSWHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
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