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 | S097 |
Date Received | 09/11/2012 |
Decision Date | 11/09/2012 |
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 TO INTRODUCE A REMOTE CONTROL (CR120) FOR USE WITH THENUCLEUS 5 (MODEL CP810) SOUND PROCESSOR FOR INTRAOPERATIVE USE TO CONDUCT IMPEDANCE AND AUTONRT, MEASUREMENTS THAT ARE COMMONLY USED DURING COCHLEAR IMPLANT SURGERY TO INDICATE THAT THE ELECTRODES ARE FUNCTIONING AND ARE STIMULATING NERVE TISSUE. |
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