PMA P960058S172
- Device
- HiResolution™ Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S172
- Product code
- MCM
- Decision date
- 2025-10-14
- Classification
- Ear, Nose, Throat
- Generic name
- Implant, cochlear
- Approval order statement
- a replacement material resin for sound processor programming cables, connector housings, and a battery cap
Current openFDA PMA Record#
- Device
- HiResolution™ Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S172
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2025-10-14
- Decision code
- OK30
- Date received
- 2025-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a replacement material resin for sound processor programming cables, connector housings, and a battery cap