MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S009 · decided 2003-08-27
Approval details
- PMA number
- P000025
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2003-03-31
- Decision date
- 2003-08-27
- Days to decision
- 149 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE COMBI 40+ SYSTEM MEDIUM ACTIVE ELECTRODE ARRAY (C40+M) TO BE PART OF THE C40+ COCHLEAR IMPLANT SYSTEM (IMPLANT C40+ WITH STANDARD C40+, SPLIT C40+ GB, AND COMPRESSED C40+ S ELECTRODE ARRAYS).
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