PMA P980023S140
- Device
- Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S140
- Product code
- LWS
- Decision date
- 2026-09-25
- Classification
- Cardiovascular
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- the next generation of the Home Monitoring Service Center (HMSC)
Current openFDA PMA Record#
- Device
- Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S140
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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)