CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) HIFOCUS ELECTRODE
FDA premarket approval P960058/S014 · decided 2000-11-15
Approval details
- PMA number
- P960058
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) HIFOCUS ELECTRODE
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2000-06-22
- Decision date
- 2000-11-15
- Days to decision
- 146 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THE CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT HIFOCUS ELECTRODE FOR PEDIATRIC USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) HIFOCUS ELECTRODE AND IS INDICATED FOR SEVERELY AND PROFOUNDLY HEARING IMPAIRED CHILDREN AGES 18-MONTHS TO 17-YEARS.
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