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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 (WCD 3000S) WEARABLE DEFIBRILLATOR
Generic NameWearable automated external defibrillator
ApplicantZOLL MANUFACTURING CORPORATION
121 GAMMA DR
PITTSBURGH, PA 15238-0000
PMA NumberP010030
Supplement NumberS005
Date Received01/21/2004
Decision Date05/03/2004
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 MODIFICATIONS TO THE LIFEVEST WCD 3000 DEVICE TO BETTER FACILITATE SHORT-TERM USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WCD 3000S 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 LIFEVEST WCD 3000S SYSTEM IS INTENDED FOR SHORT-TERM USE IN A MEDICALLY SUPERVISED ENVIRONMENT. THE DEVICE IS NOT INTENDED TO BE WORN HOME.
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