PMA P010030S196
- Device
- LifeVest® Wearable Defibrillator, Model 4000
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S196
- Product code
- MVK
- Decision date
- 2025-08-13
- Classification
- Cardiovascular
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- implementation of an automated functional test system
Current openFDA PMA Record#
- Device
- LifeVest® Wearable Defibrillator, Model 4000
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S196
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2025-08-13
- Decision code
- OK30
- Date received
- 2025-07-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of an automated functional test system