CLARION MULTI-STRATEGY COCHLEAR IMPLANT (ADULT)
FDA premarket approval P940022/S015 · decided 2000-06-16
Approval details
- PMA number
- P940022
- Supplement
- S015
- 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
- 2000-05-10
- Decision date
- 2000-06-16
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE FABRICATION PROCESS CHANGE FOR THE INTEGRATED CIRCUITS IN THE DEVICE
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