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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 NumberS028
Date Received10/31/1995
Decision Date12/11/1995
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to make changes to the mini 22 cochlear implant integrated circuit (ic) test software (k15001) in order to add several test of imporved quality assurance. One modification you have requested is to add a power supply leakage test to aid in ensuring that the bipolar tantalum power supply capacitor is not assembled in the reverse direction. The second modification you have requested is to implement an automatic evaluation of thedata mesured from the integrated circuit prior to its final assembly in order to eliminate operator error.
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