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 | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S045 |
Date Received | 10/09/2007 |
Decision Date | 11/28/2007 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODIFICATIONS TO CUSTOM SOUND 2.0 PROGRAMMING SOFTWARE TO PROVIDE SEVERAL ENHANCEMENTS TO IMPROVE THE OVERALL USEABILITY FOR THE AUDIOLOGISTS, AND THE CAPABILITY OF LINKING A FREEDOM SPEECH PROCESSOR TO AN IMPLANT VIA AN IDENTIFIER TO MINIMIZE THE POSSIBILITY OF A RECIPIENT USING THE WRONG PROCESSOR. |
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