PMA P960058S152
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S152
- Product code
- MCM
- Decision date
- 2021-04-23
- Generic name
- Implant, cochlear
- Approval order statement
- Change in colorant sub-supplier for production of cable material used in the connection between the sound processor and headpiece.
Current openFDA PMA Record#
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S152
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2021-04-23
- Decision code
- OK30
- Date received
- 2021-03-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in colorant sub-supplier for production of cable material used in the connection between the sound processor and headpiece.