- 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
- S151
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-09-25
- Decision code
- OK30
- Date received
- 2026-08-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to update manufacturing processes for high voltage capacitors in ICDs and CRT-Ds