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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 | S053 |
Date Received | 05/27/2014 |
Decision Date | 11/06/2015 |
Product Code |
MVK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE LIFEVEST WEARABLE DEFIBRILLATOR 4000 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 DEVICE AS MODIFIED IS APPROVED FOR 1) CHANGE TO THE LENGTH OF THE THERAPY ELECTRODE CHANNEL FOAM; 2) CHANGE TO THE DIMENSIONAL TOLERANCES OF THE HOLE LOCATIONS ON THE THERAPY ELECTRODELIDDING LAYER;3) CHANGE FROM ADHESIVE TO CRIMPING OF THE BATTERY CONNECTOR AND REINFORCEMENT OF THE BATTERY CELLS WITHIN THE WCD 4000 PACK; AND4) CHANGE OF MATERIAL OF THE HEX NUT USED IN THE WCD 4000 MONITOR ELECTRODE BELTRECEPTACLE FROM BRASS TO STAINLESS STEEL. |