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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 CHANNEL COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant system for children
ApplicantCOCHLEAR CORP.
PMA NumberP890027
Supplement NumberS039
Date Received07/01/1997
Decision Date12/28/1997
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expansion ofthe indication for use of hte nucleus 22 channel cochlear implant to include children 18 months and older.
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