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 | COMBI 40+ COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S035 |
Date Received | 06/25/2008 |
Decision Date | 12/19/2008 |
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 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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