Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | COMBO 40+ COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S023 |
Date Received | 03/29/2007 |
Decision Date | 09/24/2007 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order 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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