PMA P050023S165
- Device
- Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX,
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S165
- Product code
- MRM
- Decision date
- 2022-03-08
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Approval for a change to the battery cathode separator material.
Current openFDA PMA Record#
- Device
- Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX,
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S165
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2022-03-08
- Decision code
- APPR
- Date received
- 2021-12-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the battery cathode separator material.