COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S035 · decided 2008-12-19
Approval details
- PMA number
- P000025
- Supplement
- S035
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2008-06-25
- Decision date
- 2008-12-19
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE MAESTRO SYSTEM SOFTWARE VERSION 3.0 AS EXTERNAL SOFTWARE FOR USE WITH THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, INCLUDING REMOVAL OF THE CURRENT RESTRICTION REGARDING USE OF THE FSP CODING STRATEGY BY INEXPERIENCED ADULT USERS.
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