PMA P010030S110
- Device
- LifeVest Wearable Defibrilator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S110
- Product code
- MVK
- Decision date
- 2019-01-07
- Classification
- Wearable Automated External Defibrillator
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- Approval for a new software version to increase the significance and frequency of a service message.
Current openFDA PMA Record#
- Device
- LifeVest Wearable Defibrilator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S110
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2019-01-07
- Decision code
- APPR
- Date received
- 2018-10-01
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a new software version to increase the significance and frequency of a service message.