CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT VERSION 1.2
FDA premarket approval P940022/S002 · decided 1997-01-10
Approval details
- PMA number
- P940022
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT VERSION 1.2
- Applicant
- Advanced Bionics Corp.
- Date received
- 1996-11-15
- Decision date
- 1997-01-10
- Days to decision
- 56 days
- Decision code
- APPR
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR A MODIFICATION OF THE ELECTRODE COUPLING, REFERRED TO AS "ENHANCED BIPOLAR."
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