PMA P960058
- Device
- HiResolution™ Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S156
- Product code
- MCM
- Decision date
- 2026-04-16
- Generic name
- Implant, cochlear
- Approval order statement
- approval to insource the electrode wire coating process for the HiRes Ultra and Ultra 3D implants
Current openFDA PMA Record#
- Device
- HiResolution™ Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S175
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2026-04-16
- Decision code
- OK30
- Date received
- 2026-03-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to insource the electrode wire coating process for the HiRes Ultra and Ultra 3D implants