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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS097
Date Received09/11/2012
Decision Date11/09/2012
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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