|
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 | S131 |
Date Received | 12/19/2019 |
Decision Date | 01/03/2020 |
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 Location change of the supplier's production facility for components of the front response button and rear response button used in the LifeVest 4000 Monitor and the HWD 1000 Monitor. |