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
Biotronik, Inc. · Implantable cardioverter defibrillator (non-CRT) · Cardiovascular
Open FDA's page for this record- PMA number
- P980023
- Supplement number
- S146
- Applicant
- Biotronik, Inc.
- Street 1
- 6024 Jean Rd.
- City
- Lake Oswego
- State
- OR
- Zip
- 97035
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Trade name
- 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
- Product code
- LWS
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Expedited review flag
- N
- Date received
- 2026-04-15
- Decision date
- 2026-09-17
- Decision code
- APPR
- Ao statement
- approval for updated programmer software PSW 2601.U and NEO 2601.U
- Harmonized identifiers (openFDA)
- Device name
- Implantable Cardioverter Defibrillator (Non-Crt)
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3033257494, 1000165971, 3010288227, 1225687, 9610139, 3004209178, 3009380063, 1028232, 3015544746, 1828132, 2182208, 2017865, 3005334138, 3010273872, 3003932293, 3004105270, 3012552532, 3008494315, 1000121056, 3004593495, 9616693, 3002807314, 3002807561, 2022502, 2124215, 2135338, 3013674629, 3018094310, 3011120183, 2183744, 2649622, 3015453963, 3004961578, 2011171, 3002806603, 1423662, 3008988055, 3006705815, 3003120897, 3013596024 +12 more
- FEI number
- 3033257494, 1000165971, 3010288227, 3009380063, 1028232, 3015544746, 1828132, 2182208, 2017865, 3005334138, 3010273872, 3003932293, 3004105270, 3000215273, 3012552532, 3005700659, 1000121056, 3004593495, 3001451463, 3002807314, 3002807561, 2022502, 2124215, 3013674629, 3011120183, 3004369318, 3002806500, 2183744, 2649622, 3008973940, 3015453963, 3004961578, 2011171, 3002806603, 3008988055, 3006705815, 3003120897, 3013596024, 3000206435, 3003276151 +12 more