CLARION MULTI-STRATEGY COCHLEAR IMPLANT SYSTEM
FDA premarket approval P960058/S012 · decided 2000-02-02
Approval details
- PMA number
- P960058
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT SYSTEM
- Applicant
- Advanced Bionics
- Date received
- 1999-11-12
- Decision date
- 2000-02-02
- Days to decision
- 82 days
- Decision code
- APPR
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Size reduction in the speech processor known as the Platinum Sound Processor.
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