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Device | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST |
Generic Name | Wearable automated external defibrillator |
Applicant | ZOLL MANUFACTURING CORPORATION 121 GAMMA DR PITTSBURGH, PA 15238-0000 |
PMA Number | P010030 |
Supplement Number | S089 |
Date Received | 12/27/2016 |
Decision Date | 01/26/2017 |
Product Code |
MVK |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of an alternate supplier (Walco Corporation; Glenshaw, PA) to provide the pre-cut Urethane Foam (.500 x .219) used to cushion the SD card in the LifeVest units. |