PMA P010030S108
- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S108
- Product code
- MVK
- Decision date
- 2018-08-23
- Classification
- Wearable Automated External Defibrillator
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- Approval for a minor labeling update.
Current openFDA PMA Record#
- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S108
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2018-08-23
- Decision code
- APPR
- Date received
- 2018-08-08
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a minor labeling update.