COMBI 40+COCHLEAR IMPLANT SYSTEM,C40+S(COMPRESSED)ELECTRODE ARRAY/C40+ GB (SPLIT) ELECTRODE ARRAY
FDA premarket approval P000025/S001 · decided 2002-07-29
Approval details
- PMA number
- P000025
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COMBI 40+COCHLEAR IMPLANT SYSTEM,C40+S(COMPRESSED)ELECTRODE ARRAY/C40+ GB (SPLIT) ELECTRODE ARRAY
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2001-12-18
- Decision date
- 2002-07-29
- Days to decision
- 223 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, C40+S (COMPRESSED) ELECTRODE ARRAY AND THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, C40+ GB (SPLIT) ELECTRODE ARRAY.
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