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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
Generic NameWearable automated external defibrillator
ApplicantZOLL MANUFACTURING CORPORATION
121 GAMMA DR
PITTSBURGH, PA 15238-0000
PMA NumberP010030
Supplement NumberS002
Date Received02/22/2002
Decision Date03/20/2002
Product Code MVK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A NEW TRADE NAME FOR THE WCD DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND EITHER ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
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