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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 AUDITORY BRAINSTEM IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Nameauditory brainstem implant
ApplicantCOCHLEAR AMERICAS
PMA NumberP000015
Supplement NumberS011
Date Received10/13/2009
Decision Date11/12/2009
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional labeling to recipients receiving pre-programmed repaired/replaced sound processors.
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