PMA P010030S112
- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S112
- Product code
- MVK
- Decision date
- 2019-01-16
- Classification
- Wearable Automated External Defibrillator
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- Updates to the soldering process for the LifeVest Model 4000 and HWD 1000 monitors.
Current openFDA PMA Record#
- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S112
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2019-01-16
- Decision code
- OK30
- Date received
- 2018-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to the soldering process for the LifeVest Model 4000 and HWD 1000 monitors.