|
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 | S134 |
Date Received | 04/01/2020 |
Decision Date | 04/18/2020 |
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 Change in the manufacturing location of the supplier for the Electrode Belt Therapy foam cover for the LifeVest 4000 and LifeVest 4000B. |