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 | S057 |
Date Received | 10/14/2011 |
Decision Date | 04/30/2012 |
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 THE FOLLOWING: 1) +FLEX28, +FLEX24 AND FLEX24 ELECTRODE VARIANTS FOR THE SONATATI100 AND MIL000 MED-EL CONCERT COCHLEAR IMPLANTS; 2) +STANDARD, +MEDIUM AND +COMPRESSED ELECTRODE VARIANTS FOR THE SONATATI100 COCHLEAR IMPLANT; AND 3) NEW VARIANTS OF THE SINGLE USE SURGICAL INSERTION ELECTRODE TOOL (STANDARD, MEDIUM,COMPRESSED, FLEX24 AND FLEX28). |
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