MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRP+/TEMPO+ SPEECH PROCESSORS
FDA premarket approval P000025/S006 · decided 2003-03-18
Approval details
- PMA number
- P000025
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRP+/TEMPO+ SPEECH PROCESSORS
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2002-11-01
- Decision date
- 2003-03-18
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR BROADENING THE INDICATION OF THE C40+ COCHLEAR IMPLANT SYSTEM TO INCLUDE CHILDREN AGED TWELVE MONTHS OR OLDER.
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