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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
ApplicantCOCHLEAR AMERICAS
PMA NumberP970051
Supplement NumberS097
Date Received09/11/2012
Decision Date11/09/2012
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to introduce a remote control (cr120) for use with the nucleus 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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