- 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
- S196
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2025-10-24
- Decision code
- APPR
- Date received
- 2025-03-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for updates to the anode current collector manufacturing process.