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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 NumberS031
Date Received04/24/1996
Decision Date05/20/1996
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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 IMPLANT 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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