PMA P960058S155
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S155
- Product code
- MCM
- Decision date
- 2022-08-11
- Generic name
- Implant, cochlear
- Approval order statement
- Approval of a new facility at the supplier for the manufacturing of implant and headpiece magnets.
Current openFDA PMA Record#
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S155
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2022-08-11
- Decision code
- OK30
- Date received
- 2022-07-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of a new facility at the supplier for the manufacturing of implant and headpiece magnets.