- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S148
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2021-05-17
- Decision code
- OK30
- Date received
- 2021-04-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the application of a surface coating finish on the Printed Circuit Boards (PCBs) used in the LifeVest Model 4000 electrode belt therapy electrodes.