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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNUCLEUS 22 CHANNEL COCHLEAR IMPLANT
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP890027
Supplement NumberS028
Date Received10/31/1995
Decision Date12/11/1995
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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