- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S166
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2024-12-18
- Decision code
- OK30
- Date received
- 2024-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for relocation of a supplier manufacturing facility and manufacturing changes to a surgical tool used with HiRes™ Ultra CI HiFocus™ MS Electrode, HiRes™ Ultra 3D CI HiFocus™ MS Electrode and HiFocus™ Mid-Scala Electrode Insertion Tool Kit