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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 NumberS103
Date Received12/24/2012
Decision Date03/21/2013
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 TE STERILE SILICONE TEMPLATE (SST) AS A SINGLE USE SURGICAL TOOL TO HELP CHECK THE SIZE OF THE PERIOSTEAL POCKET, THE SHAPE AND DEPTH OF THE IMPLANT WELL, AND APPROPRIATE POSITIONS FOR TIE-DOWN HOLES DURING THE IMPLANT SURGICAL PROCEDURE.
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