COMBO 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S023 · decided 2007-09-24
Approval details
- PMA number
- P000025
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COMBO 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2007-03-29
- Decision date
- 2007-09-24
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE OPUS-1 EXTERNAL SPEECH PROCESSOR AND THE MAESTRO 2.0.1, WHICH ARE NEW COMPONENTS OF THE APPROVED COMBI 40+ COCHLEAR IMPLANT SYSTEM AND ARE INDICATED FOR USE ON PATIENTS WHO HAVE BEEN IMPLANTED WITH PULSARCI100 AND/OR SONATATI100 COCHLEAR IMPLANTS. THE SOFTWARE, MAESTRO 2.0.1, IS INTENDED FOR PROGRAMMING THE OPUS-1 SPEECH PROCESSOR, AND IMPLEMENTS TWO NEW SPEECH CODING STRATEGY FEATURES, HIGH DEFINITION CIS (HDCIS) AND FINE STRUCTURE PROCESSING (FSP).
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