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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.
 
DeviceCOMBI 40 + COCHLEAR IMPLANT SYSTEM AND PULSAR COCHLEAR IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantMED-EL CORP.
FURSTENWEG 77a
INNSBRUCK 6020
PMA NumberP000025
Supplement NumberS020
Date Received04/17/2006
Decision Date05/31/2006
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR NEW DIAGNOSTIC INTERFACE BOX II (DIB II). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIB II AND IS INTENDED TO OFFER THE CLINICIAN TOOLS FOR DIFFERENT CLINICAL APPLICATIONS WITH THE MED-EL COCHLEAR IMPLANT SYSTEM.
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