PMA P960058S129
- Device
- HiRes Ultra 3D Cochlear Implant
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S129
- Product code
- MCM
- Decision date
- 2018-08-28
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for the HiRes Ultra 3D Cochlear Implant and associated accessories.
Current openFDA PMA Record#
- Device
- HiRes Ultra 3D Cochlear Implant
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S129
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2018-08-28
- Decision code
- APPR
- Date received
- 2018-03-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the HiRes Ultra 3D Cochlear Implant and associated accessories.