PMA P010030S195
- Device
- LifeVest® Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S195
- Product code
- MVK
- Decision date
- 2025-07-16
- Classification
- Cardiovascular
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- approval for an alternate supplier of an injection molded monitor component
Current openFDA PMA Record#
- Device
- LifeVest® Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S195
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2025-07-16
- Decision code
- OK30
- Date received
- 2025-07-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for an alternate supplier of an injection molded monitor component