PMA P890027S028

Device: NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
Applicant: Cochlear Americas
PMA number: P890027
Supplement: S028
Product code: MCM
Decision date: 1995-12-11
Classification: Implant, Cochlear
Generic name: Implant, cochlear
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

Current openFDA PMA Record#

Device: NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
Applicant: Cochlear Americas
PMA number: P890027
Supplement: S028
Product code: MCM
Generic name: Implant, cochlear
Decision date: 1995-12-11
Decision code: APPR
Date received: 1995-10-31
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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