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. |
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Device | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P890027 |
Supplement Number | S028 |
Date Received | 10/31/1995 |
Decision Date | 12/11/1995 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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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