- Device
- Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S094
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2021-08-19
- Decision code
- OK30
- Date received
- 2021-07-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement new automated equipment for their pickling process associated with various components used in manufacture of IPGs, ICDs, and leads.