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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 3100) DEVICE
Generic NameWearable automated external defibrillator
ApplicantZOLL MANUFACTURING CORPORATION
121 GAMMA DR
PITTSBURGH, PA 15238-0000
PMA NumberP010030
Supplement NumberS007
Date Received03/06/2006
Decision Date11/01/2006
Product Code MVK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR HARDWARE CHANGE TO INTEGRATE THE PENDANT ALARM MODULE INTO THE MONITOR ENCLOSURE, HARDWARE CHANGE TO THE COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY TO IMPROVE EMI IMMUNITY AND REPLACE SEVERAL OBSOLETE COMPONENTS, SOFTWARE CHANGES TO INTERACT WITH THE REVISED COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY, LABELING CHANGES TO ACCOMMODATE THE INTEGRATED ALARM MODULE, AND TO IMPROVE READABILITY, LABELING CHANGES TO PROVIDE A SPANISH VERSION OF THE PATIENT MANUAL, PATIENT CHECKLIST, AND CORRESPONDING AUDIO/DISPLAY MESSAGES FOR SPANISH SPEAKING PATIENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WCD 3100 AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
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