|
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 | S130 |
Date Received | 12/17/2019 |
Decision Date | 12/19/2019 |
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
Use of an alternate automated gel dispensing method during the manufacture of the LifeVest model 4000 therapy electrodes. |