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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 AUDITORY BRAINSTEM IMPLANT (ABI)
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP000015
Supplement NumberS005
Date Received06/24/2003
Decision Date08/22/2003
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A POLYTEREPHTHALATE (PET) MESH DISK. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT WITH PET MESH DISK AND IS INTENDED TO RESTORE USEFUL HEARING IN INDIVIDUALS WITH NEUROFIBROMATOSIS TYPE 2 (NF2) WHO ARE 12 YEARS OF AGE OR OLDER, VIA ELECTRICAL STIMULATION OF THE COCHLEAR NUCLEUS.
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