CLARION MULTI-STRATEGY COCHLEAR IMPLANT
Advanced Bionics · Implant, cochlear · Ear, Nose, Throat
Open FDA's page for this record- PMA number
- P960058
- Supplement number
- S178
- Applicant
- Advanced Bionics
- Street 1
- 28515 Westinghouse Pl.
- City
- Valencia
- State
- CA
- Zip
- 91355
- Generic name
- Implant, cochlear
- Trade name
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT
- Product code
- MCM
- Advisory committee
- EN
- Advisory committee description
- Ear, Nose, Throat
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Expedited review flag
- N
- Date received
- 2026-08-21
- Decision date
- 2026-09-18
- Decision code
- APPR
- Ao statement
- The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P960058/S167.
- Harmonized identifiers (openFDA)
- Device name
- Implant, Cochlear
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3009092818, 3013177549, 3008947133, 3034170504, 3030784382, 8043792, 3012654499, 3010363503, 9710014, 3002806740, 3005900820, 1721676, 3005210579, 9611813, 9613646, 3009762645, 3011823740, 3033788852, 3002808022, 3020283264, 3007743836, 3014579188, 2030624
- FEI number
- 3009092818, 3013177549, 3008947133, 3034170504, 3030784382, 3000249315, 3012654499, 3010363503, 3002806740, 3005900820, 1721676, 3005210579, 3000206435, 3011823740, 3002806685, 3002808269, 3033788852, 3002808022, 3003045432, 1000220815, 3020283264, 3007743836, 3014579188