PMA P960058S168
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S168
- Product code
- MCM
- Decision date
- 2025-04-09
- Classification
- Ear, Nose, Throat
- Generic name
- Implant, cochlear
- Approval order statement
- the use of a contract sterilizer for the Ultra and Ultra 3D cochlear implant devices and accessories
Current openFDA PMA Record#
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S168
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2025-04-09
- Decision code
- OK30
- Date received
- 2025-02-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the use of a contract sterilizer for the Ultra and Ultra 3D cochlear implant devices and accessories