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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
Classification Nameimplant, cochlear
Generic Namecochlear implant
ApplicantCOCHLEAR CORP.
PMA NumberP840024
Supplement NumberS063
Date Received04/25/1996
Decision Date06/20/1996
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revisions to the warnings section in the pacakge insert and patient identification card for the nucleus 22 cochlear implant system. The revisions clarify the warning on the use of monopolar electrosurgical instruments on implant patients and provides use of monopolar electrosurgical instruments on implant patients and provides addtionial instructions for the safe use of bipolar instruments.
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