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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
Classification Nameimplant, cochlear
Generic Namecochlear implant
ApplicantCOCHLEAR CORP.
PMA NumberP840024
Supplement NumberS046
Date Received08/28/1992
Decision Date08/21/1995
Product Code
MCM[ Registered Establishments with MCM ]
Docket Number 95M-0398
Notice Date 12/19/1995
Advisory Committee Ear Nose & Throat
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for nucleus 22-channel cochlear implant for use in an expanded adult population.
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