PMA P010030S193
- Device
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S193
- Product code
- MVK
- Decision date
- 2025-05-30
- Classification
- Cardiovascular
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- approval for a process change to the joining method of cable components at the existing supplier
Current openFDA PMA Record#
- Device
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S193
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2025-05-30
- Decision code
- OK30
- Date received
- 2025-05-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a process change to the joining method of cable components at the existing supplier