PMA P960058S178
- Device
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S178
- Product code
- MCM
- Decision date
- 2026-09-18
- Classification
- Ear, Nose, Throat
- Generic name
- Implant, cochlear
- Approval order statement
- The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P960058/S167.
Current openFDA PMA Record#
- Device
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S178
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2026-09-18
- Decision code
- APPR
- Date received
- 2026-08-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P960058/S167.