PMA P010030S194
- Device
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S194
- Product code
- MVK
- Decision date
- 2025-07-16
- Classification
- Cardiovascular
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- the removal of a test step performed on device components that have been returned after patient use
Current openFDA PMA Record#
- Device
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S194
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2025-07-16
- Decision code
- OK30
- Date received
- 2025-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the removal of a test step performed on device components that have been returned after patient use