- Device
- LifeVest Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S134
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2020-04-18
- Decision code
- OK30
- Date received
- 2020-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the manufacturing location of the supplier for the Electrode Belt Therapy foam cover for the LifeVest 4000 and LifeVest 4000B.