- Device
- Ilivia Neo 7 VR-T DX DF-1 ProMRI, Ilivia Neo 7 VR-T DF-1 ProMRI, Intica Neo 7 VR-T DX DF-1 ProMRI, Intica Neo 7 VR-T DF-
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S152
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-10-13
- Decision code
- OK30
- Date received
- 2026-09-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the rework process for the manufacturing of the housing for pulse generators and ICDS