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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.
 
DeviceCI24R(ST) COCHLEAR IMPLANT
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS010
Date Received02/23/2000
Decision Date08/21/2000
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  
APPROVAL FOR A DESIGN MODIFICATION INCLUDING THE STRAIGHT ELECTRODE OF THE CI 24 M WITH THE 24 K DOWNSIZED STIMULATOR RECEIVER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CI 24R(ST), AND IS INDICATED FOR CHILDREN AGE 18 MONTHS THROUGH 17 YEARS OF AGE WHO HAVE BILATERAL PROFOUND SENSORINEURAL DEAFNESS AND DEMONSTRATE LITTLE OR NO BENEFIT FROM APPROPRIATE BINAURAL HEARING AIDS, AND FOR ADULTS, AGE 18 YEARS AND OLDER WHO HAVE BILATERAL MODERATE TO PROFOUND SENSORINEURAL HEARING LOSS AND OBTAIN LIMITED BENEFIT FROM APPROPRIATE HEARING AIDS.
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