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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 NumberS037
Date Received04/13/2006
Decision Date05/25/2006
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) SMALLER AND MORE COSMETIC, EAR-LEVEL CONTROLLER (POWERED BY TWO 675 HEARING-AID BATTERIES) AND 2) A RECHARGEABLE LITHIUM-ION BATTERY ? BOTH FOR USE WITH THE MODULAR NUCLEUS FREEDOM SPEECH PROCESSOR.
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