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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 22 COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant system for children
ApplicantCOCHLEAR AMERICAS
PMA NumberP890027
Supplement NumberS056
Date Received09/14/2007
Decision Date10/16/2007
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to custom sound programming software to provide receipts of previous generation nucleus 22 cochlear implants with access to the nucleus freedom speech processor.
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