PMA P980023
- Device
- Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky VR-T DX, Riva
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S118
- Product code
- LWS
- Decision date
- 2026-05-07
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- laser machine manufacturing parameter adjustments
Current openFDA PMA Record#
- Device
- Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky VR-T DX, Riva
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S145
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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