PMA P960058S174
- Device
- HiResolution™ Bionic Ear System Ultra and Ultra 3D Thin PCB
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S174
- Product code
- MCM
- Decision date
- 2026-04-09
- Classification
- Ear, Nose, Throat
- Generic name
- Implant, cochlear
- Approval order statement
- approval of an alternate flex layer on the printed circuit board used for the implants in the HiResolution™ Bionic Ear System
Current openFDA PMA Record#
- Device
- HiResolution™ Bionic Ear System Ultra and Ultra 3D Thin PCB
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S174
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2026-04-09
- Decision code
- OK30
- Date received
- 2026-03-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of an alternate flex layer on the printed circuit board used for the implants in the HiResolution™ Bionic Ear System