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 SYSTEM |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P840024 |
Supplement Number | S062 |
Date Received | 04/24/1996 |
Decision Date | 05/20/1996 |
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 MODIFICATIONS TO THE EXTERNAL TRANSMITTER COIL OF THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT DEVICE. THE MODIFICATIONS CONSIST OF CONNECTING TWO DIODES IN PARALLEL WITH THE EXTERNAL TRANSMITTER COIL TO LIMIT ESD ENERGY BEING TRANSMITTED TO THE IMPALNT BY THE COIL. A CHANGE IN THE MANUFACTURING METHOD FOR THE COIL WINDINGS WILL ALSO REDUCE THE EFFECTIVE COIL DIAMETER BY APPROXIMATELY 0.1MM. |
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