CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT VERSION 1.2
FDA premarket approval P940022/S001 · decided 1996-08-02
Approval details
- PMA number
- P940022
- Supplement
- S001
- 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
- 1996-04-05
- Decision date
- 1996-08-02
- Days to decision
- 119 days
- Decision code
- APPR
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL TO MODIFY THE DESIGN OF THE CLARION MULTI-STRATEGY COCHLEAR IMPALTN FROM THE ORIGINAL 1.0 VERSION TO THE MINIATURIZED 1.2 VERSION
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