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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 NumberS096
Date Received08/27/2012
Decision Date08/02/2013
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the nucleus 6 cochlear implant system, a new suite of external accessories and programming software to be used with the nucleus 24 cochlear implant, including external sound processors (cp910 and cp920), user remote assistants (cr210 and cr230), intraoperative remote assistant (cr220), and programming software (custom sound suite 4 comprised of custom sound 4 and custom sound ep 4).
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