- Device
- Iforia 7, Ilesto 5, Iforia 5, Itrevia 7, Iperia 7, Ilivia 7, Intica 7, Intica 5, Inlexa 3, Inventra 7, Itrevia 5, Iperia
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S163
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2021-10-29
- Decision code
- OK30
- Date received
- 2021-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Optimize the sterilization process parameters for P01 and P02 and propose a load change for P01.