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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 NameNUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL
Classification Nameimplant, cochlear
Generic Namecochlear implant system for children
ApplicantCOCHLEAR CORP.
PMA NumberP890027
Supplement NumberS002
Date Received02/28/1991
Decision Date05/16/1991
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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