PMA P010030S107
- Device
- LifeVest Wearable Defibrilator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S107
- Product code
- MVK
- Decision date
- 2019-02-27
- Classification
- Wearable Automated External Defibrillator
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- Approval for an alternate gel supplier.
Current openFDA PMA Record#
- Device
- LifeVest Wearable Defibrilator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S107
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2019-02-27
- Decision code
- APPR
- Date received
- 2018-05-04
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate gel supplier.