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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 COCHLEAR IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS049
Date Received12/19/2008
Decision Date08/24/2009
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 THE FOLLOWING NEW COMPONENTS OF THE COCHLEAR IMPLANT SYSTEM: CP810 SOUND PROCESSOR, CR110 REMOTE ASSISTANT, CUSTOM SOUND 3.0 PROGRAMMING SOFTWARE.
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