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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 NumberS006
Date Received03/09/2005
Decision Date03/30/2005
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change of supplier for three silicone products (silicone hcrp 50, silicone lsr 30, and rtv silicone adhesive) and change the catalyst in two additional silicone products (med4515 & med4516).
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