PMA P010030S091
- Device
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S091
- Product code
- MVK
- Decision date
- 2018-08-03
- Classification
- Wearable Automated External Defibrillator
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- Approval for display of S3, S4, and EMAT heart sounds parameters.
Current openFDA PMA Record#
- Device
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S091
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2018-08-03
- Decision code
- APPR
- Date received
- 2017-01-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for display of S3, S4, and EMAT heart sounds parameters.