PMA P960058S156
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S156
- Product code
- MCM
- Decision date
- 2022-09-09
- Generic name
- Implant, cochlear
- Approval order statement
- Facility move at a supplier for manufacture of implant parts used in the assembly of the HiRes Ultra and HiRes Ultra 3D cochlear implants.
Current openFDA PMA Record#
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S156
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2022-09-09
- Decision code
- OK30
- Date received
- 2022-08-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Facility move at a supplier for manufacture of implant parts used in the assembly of the HiRes Ultra and HiRes Ultra 3D cochlear implants.