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 | S025 |
Date Received | 10/04/1994 |
Decision Date | 02/13/1996 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR COMPONENT AND PROCESS CHANGES TO THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT DEVICE. THE COMPONENT CHANGE CONSISTS OF REPLACING THE LOWER VALUE NPO DIELECTRIC TRIM CAPACITOR WITH THE SAME BX DIELECTRIC MATERIAL AS USED FOR THE HIGHER VALUE TRIM CAPACITOR. THE PROCESS CHANGE CONSISTS OF PREHEATING THE CAPACITORS AND PRINTED CIRCUIT BOARD PRIOR TO SOLDERING THE CAPACITORS TO THE PCB |
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