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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.
Classification Nameimplant, cochlear
Generic Namenucleus 24 cochlear implant system (softip)
PMA NumberP970051
Supplement NumberS021
Date Received07/16/2002
Decision Date11/22/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor design modification to the contour 24 cochlear implant electrode. The device, as modified, will be marketed under the trade name contour softip electrode.