PMA P010030S074
- Device
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 4000 LIFEVEST
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S074
- Product code
- MVK
- Decision date
- 2016-07-18
- Classification
- Wearable Automated External Defibrillator
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- Approval for a larger capacity battery pack and associated modifications to the battery pack connection to the printed circuit assembly (PCA) for the WCD 4000 System. This device is indicated for patients of all ages who are at risk for sudden cardiac arrest and either not candidates for or refuse an implantable defibrillator.
Current openFDA PMA Record#
- Device
- WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 4000 LIFEVEST
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S074
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2016-07-18
- Decision code
- APPR
- Date received
- 2016-04-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a larger capacity battery pack and associated modifications to the battery pack connection to the printed circuit assembly (PCA) for the WCD 4000 System. This device is indicated for patients of all ages who are at risk for sudden cardiac arrest and either not candidates for or refuse an implantable defibrillator.