PMA P010030
- Device
- LifeVest® Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S163
- Product code
- MVK
- Decision date
- 2026-09-09
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- approval for an additional battery pack variant for the LifeVest 5100 to be manufactured by a new Tier 1 supplier
Current openFDA PMA Record#
- Device
- LifeVest® Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S201
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2026-09-09
- Decision code
- APPR
- Date received
- 2026-06-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for an additional battery pack variant for the LifeVest 5100 to be manufactured by a new Tier 1 supplier