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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 COCHLEAR IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Dr.
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS034
Date Received09/23/2005
Decision Date10/21/2005
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 AN ALTERNATIVE CABLE AND CONNECTOR (ALSO KNOWN AS SHOE) TO BE USED WITH THE PREVIOUSLY APPROVED NUCLEUS FREEDOM BODYWORN PROCESSOR. THE ALTERNATIVE CABLE/SHOE HAS BEEN DESIGNED TO BE COMPATIBLE WITH WIRELESS FM COMMUNICATION SYSTEMS MANUFACTURED BY PHONAK HEARING SYSTEMS.
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