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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 NumberS056
Date Received02/19/2013
Decision Date12/17/2015
Product Code MVK 
Docket Number 15M-3521
Notice Date 12/24/2015
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE LIFEVEST WEARABLE CARDIOVERTER DEFIBRILLATOR, MODELS 3000, 3100, AND 4000. THE LIFEVEST SYSTEM IS INDICATED FOR PATIENTS 18 YEARS OF AGE AND OLDER WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR. THE LIFEVEST SYSTEM ISINDICATED FOR PATIENTS UNDER 18 YEARS OF AGE WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR. PATIENTS MUST HAVE A CHEST CIRCUMFERENCE OF 26 INCHES (66 CENTIMETERS) OR GREATER AND A WEIGHT OF 18.75 KILOGRAMS (41.3 POUNDS) OR GREATER.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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