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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 24 CONTOUR COCHLEAR IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS011
Date Received07/21/2000
Decision Date11/01/2000
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  
MODIFICATION OF THE ELECTRODE FOR THE NUCLEUS CI24 COCHLEAR IMPLANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM WITH THE FOLLOWING CHANGES TO THE INDICATIONS FOR USE: 1) APPROVAL TO IMPLANT INDIVIDUALS, AGE 18 YEARS AND OLDER, WHO OBTAIN LIMITED BENEFIT FROM AMPLIFICATION AS DEFINED BY TEST SCORES OF <=50% CORRECT IN THE EAR TO BE IMPLANTED, (<=60% IN THE BEST AIDED LISTENING CONDITION) ON TAPE RECORDED TESTS OF OPEN SET SENTENCE RECOGNITION. 2) APPROVAL TO IMPLANT CHILDREN 12 MONTHS OF AGE AND OLDER WHO HAVE BILATERAL PROFOUND SENSORINEURAL HEARING LOSS AND OBTAIN LIMITED BENEFIT FROM APPROPRIATELY FITTED HEARING AIDS.
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