PMA P960058S139
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S139
- Product code
- MCM
- Decision date
- 2019-07-18
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for a new headpiece variant, the UHP 3D Plus and associated magnets, 3D Magnet Max and 3D Magnet Plus.
Current openFDA PMA Record#
- Device
- HiResolution Bionic Ear System
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S139
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2019-07-18
- Decision code
- APPR
- Date received
- 2019-05-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new headpiece variant, the UHP 3D Plus and associated magnets, 3D Magnet Max and 3D Magnet Plus.