- Device
- LifeVest® Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S158
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2023-01-17
- Decision code
- APPR
- Date received
- 2022-04-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design changes to the therapy electrode that include increasing the strength of the ring seals, transition from solid leads to stranded leads and removal of a redundant component.