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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 FOR ADULTS AND CHILDREN WITH CI 11=11=2M DOUBLE ARRAY COCHLEAR IMPLANT
Classification Nameimplant, cochlear
Generic Namenucleus 24 cochlear implant system
ApplicantCOCHLEAR AMERICAS
PMA NumberP970051
Supplement NumberS015
Date Received03/19/2001
Decision Date06/06/2002
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 the nucleus 24 cochlear implant system for adults and children with ci 11+11+2m double array cochlear implant. The device, as modified, will be marketed under the trade name nucleus 24 implant system for adults and children with 11+11+2m double array and is indicated for patients who have cochlear ossification preventing full insertion of a standard nucleus 24 cochlear implant electrode array.
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