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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 COCHLEAR IMPLANT SYSTEM (ADULTS)
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Dr.
Lone Tree, CO 80124
PMA NumberP840024
Supplement NumberS086
Date Received12/16/2002
Decision Date12/27/2002
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATION OF THE COIL/CABLE OF THE ESPRIT 3G SPEECH PROCESSOR TO ENABLE NUCLEUS 22 USERS TO ACCESS THE TECHNOLOGICAL BENEFITS OF THE ESPRIT 3G.
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