CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)
FDA premarket approval P960058/S011 · decided 1999-11-18
Approval details
- PMA number
- P960058
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)
- Applicant
- Advanced Bionics
- Date received
- 1999-09-30
- Decision date
- 1999-11-18
- Days to decision
- 49 days
- Decision code
- APPR
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for the SCLIN 2000 Device Fitting Software for the CLARION(TM) Multi-Strategy Cochlear Implant (Pediatric).
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