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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 Drive
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS038
Date Received04/21/2006
Decision Date06/14/2006
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 1) VERSION 1.3 OF THE CUSTOM SOUND PROGRAMMING SOFTWARE WHICH INCLUDES SOFTWARE MODIFICATIONS AND ENHANCEMENTS WHICH WILL ENABLE RECIPIENTS OF THE PREVIOUS GENERATION NUCLEUS 24 COCHLEAR IMPLANTS TO USE THE LATEST APPROVED FREEDOM SPEECH PROCESSOR, AND 2) FREEDOM PROCESSOR FIRMWARE CHANGES RELATED TO THE PROCESSORS LIQUID-CRYSTAL DISPLAY (LCD).
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