PMA P000009S122
- Device
- Ilivia Neo 7 DR-T; Intica Neo 7 DR-T; Intica Neo 5 DR-T
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S122
- Product code
- MRM
- Decision date
- 2025-10-01
- Classification
- Cardiovascular
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- introducing a temporary, additional incoming visual inspection of outer packaging
Current openFDA PMA Record#
- Device
- Ilivia Neo 7 DR-T; Intica Neo 7 DR-T; Intica Neo 5 DR-T
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S122
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2025-10-01
- Decision code
- APPR
- Date received
- 2025-09-05
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introducing a temporary, additional incoming visual inspection of outer packaging