- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S131
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2020-01-03
- Decision code
- OK30
- Date received
- 2019-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Location change of the supplier's production facility for components of the front response button and rear response button used in the LifeVest 4000 Monitor and the HWD 1000 Monitor.