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 | MED - EL COMBI 40+ COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S050 |
Date Received | 12/27/2010 |
Decision Date | 07/22/2011 |
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 |
Approval Order Statement APPROVAL FOR AN UPDATED VERSION OF THE MED-EL COMBI 40+ COCHLEAR IMPLANTSYSTEM REFERRED TO AS MAESTRO 2010 CONSISTING OF THE FOLLOWING FEATURES: 1) A THINNER VERSION OF THE SONATATI- 100 COCHLEAR IMPLANT, THE MI1000 MED-EL CONCERT;2) SEVERAL DESIGN AND MANUFACTURING UPDATES RELATED TO THE INTRODUCTION OF THE MI1000 MEDEL CONCERT; 3) NEW TASKS AND FUNCTIONALITIES ADDED TO THE MAESTRO FITTING SOFTWARE IN MAESTRO 4.0; 4) A SELECTION OF NEW COLORS AVAILABLE FOR THE OPUS 2 AUDIO PROCESSOR AND; 5) A NEW, MORE ENERGY-EFFICIENT, AUDIO PROCESSOR COIL CALLED D-COIL. |
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