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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 COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
ApplicantCOCHLEAR AMERICAS
PMA NumberP970051
Supplement NumberS093
Date Received07/31/2012
Decision Date01/03/2013
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 a new version of the custom sound software for programming of the nucleus cochlear implants, to be known as custom sound 3. 3.
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