PMA P010030S130
- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S130
- Product code
- MVK
- Decision date
- 2019-12-19
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- Use of an alternate automated gel dispensing method during the manufacture of the LifeVest model 4000 therapy electrodes.
Current openFDA PMA Record#
- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S130
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2019-12-19
- Decision code
- OK30
- Date received
- 2019-12-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an alternate automated gel dispensing method during the manufacture of the LifeVest model 4000 therapy electrodes.