PMA P050023S204
- Device
- Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7 VR-T 404634; I
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S204
- Product code
- MRM
- Decision date
- 2026-09-25
- Classification
- Cardiovascular
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- the next generation of the Home Monitoring Service Center (HMSC)
Current openFDA PMA Record#
- Device
- Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7 VR-T 404634; I
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S204
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2026-09-25
- Decision code
- APPR
- Date received
- 2025-09-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- the next generation of the Home Monitoring Service Center (HMSC)