PMA P010030S159
- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S159
- Product code
- MVK
- Decision date
- 2022-06-01
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- Automation of two processes and a solder flux material change used during the manufacture of printed circuit assemblies (PCAs).
Current openFDA PMA Record#
- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S159
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2022-06-01
- Decision code
- OK30
- Date received
- 2022-05-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automation of two processes and a solder flux material change used during the manufacture of printed circuit assemblies (PCAs).