PMA P000009S119
- Device
- Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S119
- Product code
- MRM
- Decision date
- 2025-03-05
- Classification
- Cardiovascular
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- an alternative supplier, replacement material, and updated processing steps for battery manufacturing
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
- S119
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2025-03-05
- Decision code
- OK30
- Date received
- 2025-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternative supplier, replacement material, and updated processing steps for battery manufacturing