MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)
FDA premarket approval P960058/S008 · decided 1999-01-19
Approval details
- PMA number
- P960058
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)
- Applicant
- Advanced Bionics
- Date received
- 1998-10-27
- Decision date
- 1999-01-19
- Days to decision
- 84 days
- Decision code
- APPR
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for expansion of the indication for use of the Advanced Bionics CLARION Multi-Strategy Cochlear Implant to include children 18 months and older.
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