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 | S013 |
Date Received | 01/26/2004 |
Decision Date | 02/25/2004 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF AN ALTERNATIVE SUPPLIER FOR THE ELECTRODE WIRE USED IN THE MED-EL COMBI 40+ COCHLEAR IMPLANT. |
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