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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
Classification Nameimplant, cochlear
Generic Namecochlear implant system for children
ApplicantCOCHLEAR CORP.
PMA NumberP890027
Supplement NumberS030
Date Received02/23/1996
Decision Date04/04/1996
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
Approval Order Statement 
Modifications to the audio input selector (ais), an optional accessory for the nucleus 22 channel cochlear implant device. The modifications consist of replacing the augat, type ase/f/fo series switches with augat, ype mms series switches and remounting resistors r1 and r2 to the surface of the pcb.
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