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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 NumberS002
Date Received07/23/2001
Decision Date01/07/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the most recent software version for the neural response telemetry (nrtv3) to be used with this device.
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