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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 SYSTEM
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP840024
Supplement NumberS068
Date Received12/09/1996
Decision Date04/04/1997
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 MARKETING OF THE AUDALLION BEAM FORMING PRE-PROCESSOR AND FOR APPROVAL OF DEVICE EFFECTIVENESS CLAIMS FOR THE AUDALLIN AS USED WIT THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (SPEAK SPEECH PROCESSOR). THE AUDALLION IS INDICATED FOR USE BY ADULTS WHO ARE USING THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM TO AID THEM IN IMPROVING SPEECH UNDERSTADNING IN NOISY ENVIRONMENTS WHEN THE SPEECH AND THE NOISE ARE NOT COMING FROM THE SAME DIRECTION
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