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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 22 CHANNEL COCHLEAR IMPLANT SYSTEM (ADULT)
Classification Nameimplant, cochlear
Generic Namecochlear implant (adult)
ApplicantCOCHLEAR CORP.
PMA NumberP840024
Supplement NumberS078
Date Received04/15/1999
Decision Date05/07/1999
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested a manufacturing process change from freon to lenium ts for use in the expansion of silicone tubing and moldings.
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