MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S002 · decided 2002-07-11
Approval details
- PMA number
- P000025
- Supplement
- S002
- 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
- 2002-02-21
- Decision date
- 2002-07-11
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE REPLACEMENT OF COMBI 40+ COCHLEAR IMPLANT SYSTEM DOS BASED SOFTWARE WITH CI.STUDIO+, VERSION 1.0 SOFTWARE, FOR "REMOTE CONSULTATIVE SERVICES".
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