PMA P960058S170
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S170
- Product code
- MCM
- Decision date
- 2026-01-23
- Classification
- Ear, Nose, Throat
- Generic name
- Implant, cochlear
- Approval order statement
- a change of the raw material used for the HiRes Ultra Mock-Up device
Current openFDA PMA Record#
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S170
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2026-01-23
- Decision code
- APPR
- Date received
- 2025-05-16
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change of the raw material used for the HiRes Ultra Mock-Up device