CLARION MULTI-STRATEGY COCHLEAR IMPLANT (ADULT)
FDA premarket approval P940022/S012 · decided 1999-11-08
Approval details
- PMA number
- P940022
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT (ADULT)
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics Corp.
- Date received
- 1999-09-30
- Decision date
- 1999-11-08
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the SCLIN 2000 Device Fitting Software for the CLARION(R) Multi-Strategy Cochlear Implant (Adult).
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