Ilivia 7 VRT DX, Intica 7 VRT DX, Intica 5 VRT DX, Ilivia 7 VRT, Intica 7 VRT, Intica 5 VRT, Inlexa 7 VRT, Inlexa 7 VRT
Biotronik, Inc. · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER · Cardiovascular
Open FDA's page for this record- PMA number
- P050023
- Supplement number
- S216
- Applicant
- Biotronik, Inc.
- Street 1
- 6024 Jean Rd.
- City
- Lake Oswego
- State
- OR
- Zip
- 97035
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Trade name
- Ilivia 7 VRT DX, Intica 7 VRT DX, Intica 5 VRT DX, Ilivia 7 VRT, Intica 7 VRT, Intica 5 VRT, Inlexa 7 VRT, Inlexa 7 VRT
- Product code
- MRM
- 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
- Defibrillator, Implantable, Dual-Chamber
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3002806603, 1000165971, 3008159616, 1028232, 3005941719, 9610139
- FEI number
- 3002806603, 1000165971, 3008159616, 1028232, 3002807111, 3002806500