PMA P010030S154
- Device
- LifeVest® Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S154
- Product code
- MVK
- Decision date
- 2021-11-04
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- Additional tier-1 supplier of a component of the therapy electrode used in the LifeVest 4000 Electrode Belts.
Current openFDA PMA Record#
- Device
- LifeVest® Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S154
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2021-11-04
- Decision code
- OK30
- Date received
- 2021-10-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional tier-1 supplier of a component of the therapy electrode used in the LifeVest 4000 Electrode Belts.