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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 (ABI)
Classification Nameimplant, cochlear
Generic Nameauditory brainstem implant
ApplicantCOCHLEAR AMERICAS
PMA NumberP000015
Supplement NumberS008
Date Received09/05/2006
Decision Date10/05/2006
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional ethylene oxide (eo) sterilizer and change to a new size of ethylene oxide canister.
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