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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 WITH CONTOUR ADVANCE
Classification Nameimplant, cochlear
Generic Namenucleus 24 cochlear implant system (softip)
ApplicantCOCHLEAR AMERICAS
PMA NumberP970051
Supplement NumberS025
Date Received08/13/2003
Decision Date11/07/2003
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of a marketing name change from nucleus 24 cochlear implant system with contour softip electrode to nucleus 24 contour advance.
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