- Device
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S191
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2025-05-30
- Decision code
- APPR
- Date received
- 2025-03-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for implementation of a software update to the LifeVest 5100 Monitor and Electrode Belt software to software version V0006