CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)
FDA premarket approval P960058/S013 · decided 2000-06-16
Approval details
- PMA number
- P960058
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- 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
- Valencia, CA
- Statement
- APPROVAL FOR THE FABRICATION PROCESS CHANGE FOR THE INTEGRATED CIRCUITS IN THE DEVICE.
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