PMA P010030S150
- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S150
- Product code
- MVK
- Decision date
- 2021-09-01
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- Approval for the use of a new lithium-ion battery pack for the LifeVest 4000 device
Current openFDA PMA Record#
- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S150
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2021-09-01
- Decision code
- APPR
- Date received
- 2021-06-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the use of a new lithium-ion battery pack for the LifeVest 4000 device