PMA P010030S114
- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S114
- Product code
- MVK
- Decision date
- 2019-03-13
- Classification
- Wearable Automated External Defibrillator
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- New solder paste printer and solder paste inspection system on the Surface Mount Line used during the PCA manufacturing process.
Current openFDA PMA Record#
- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S114
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2019-03-13
- Decision code
- OK30
- Date received
- 2019-02-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New solder paste printer and solder paste inspection system on the Surface Mount Line used during the PCA manufacturing process.