PMA P000009S124
- Device
- Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S124
- 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 Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S124
- 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)