PMA P010030S111
- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S111
- Product code
- MVK
- Decision date
- 2019-02-28
- Classification
- Wearable Automated External Defibrillator
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- Approval for a material change to the flex tail used in the monitor response button and minor dimensional changes to the enclosure cover.
Current openFDA PMA Record#
- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S111
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2019-02-28
- Decision code
- APPR
- Date received
- 2018-12-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a material change to the flex tail used in the monitor response button and minor dimensional changes to the enclosure cover.