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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
Generic Namenucleus 24 cochlear implant system (softip)
ApplicantCOCHLEAR AMERICAS
PMA NumberP970051
Supplement NumberS045
Date Received10/09/2007
Decision Date11/28/2007
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 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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