CLARION MULTI-STRATEGY COCHLEAR IMPLANT(ADULT)
FDA premarket approval P940022/S010 · decided 1999-03-22
Approval details
- PMA number
- P940022
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT(ADULT)
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics Corp.
- Date received
- 1999-02-04
- Decision date
- 1999-03-22
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for an alternate sterilization site located at Griffith Micro Science, Inc., 5725 West Harold Gatty Drive, Salt Lake City, Utah 84116.
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