Ilivia Neo 7 VRT DX, Intica Neo 7 VRT DX, Intica Neo 5 VRT DX, Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Ri
Biotronik, Inc. · Implantable cardioverter defibrillator (non-CRT) · Cardiovascular
Open FDA's page for this record- PMA number
- P980023
- Supplement number
- S153
- Applicant
- Biotronik, Inc.
- Street 1
- 6024 Jean Rd.
- City
- Lake Oswego
- State
- OR
- Zip
- 97035
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Trade name
- Ilivia Neo 7 VRT DX, Intica Neo 7 VRT DX, Intica Neo 5 VRT DX, Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Ri
- Product code
- LWS
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-09-22
- Decision date
- 2026-10-22
- Decision code
- OK30
- Ao statement
- updating visual and dimensional incoming inspection testing for certain components and raw materials used in IPG, ICD, and lead manufacturing
- Harmonized identifiers (openFDA)
- Device name
- Implantable Cardioverter Defibrillator (Non-Crt)
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3015544746, 3004961578, 3018094310, 2649622, 3008159616, 2030624, 1828132, 1000121056, 2022502, 2124215, 3015453963, 3033257494, 9614453, 3003120897, 2183744, 3002806603, 2133641, 3013674629, 1225687, 9616693, 1028232, 3010273872, 1423662, 3010288227, 9610139, 2017865, 3005334138, 3012552532, 3003276151, 2183787, 3013596024, 3013500228, 3008494315, 3003932293, 3004105270, 2182208, 3013288201, 2032521, 1000165971, 2648729 +12 more
- FEI number
- 3015544746, 3000203466, 3004961578, 3002807576, 3018094310, 2649622, 3008159616, 1828132, 1000121056, 2022502, 2124215, 3015453963, 3033257494, 3003120897, 2183744, 3002806603, 3003574398, 3013674629, 1028232, 3010273872, 3000215273, 3010288227, 2017865, 3005334138, 3002806500, 3012552532, 3003276151, 2183787, 3005700659, 3013596024, 3013500228, 3000206435, 3001451463, 3003932293, 3002618605, 3004105270, 2182208, 3013288201, 3004369318, 1000165971 +12 more