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Device | LIFEVEST WEARABLE DEFIBRILLATOR |
Generic Name | Wearable automated external defibrillator |
Applicant | ZOLL MANUFACTURING CORPORATION 121 GAMMA DR PITTSBURGH, PA 15238-0000 |
PMA Number | P010030 |
Supplement Number | S056 |
Date Received | 02/19/2013 |
Decision Date | 12/17/2015 |
Product Code |
MVK |
Docket Number | 15M-3521 |
Notice Date | 12/24/2015 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |