PMA P050023S210
- 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
- S210
- Product code
- MRM
- Decision date
- 2026-05-07
- Classification
- Cardiovascular
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- laser machine manufacturing parameter adjustments
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
- S210
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2026-05-07
- Decision code
- OK30
- Date received
- 2026-04-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- laser machine manufacturing parameter adjustments