- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S106
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2018-07-16
- Decision code
- APPR
- Date received
- 2018-05-03
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to move the manufacturing site of two transformers in the high voltage printed circuit board from Butler, Pennsylvania, to Gowanda, New York.