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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
Generic NameImplant, cochlear
ApplicantMED-EL CORP.
FURSTENWEG 77a
INNSBRUCK 6020
PMA NumberP000025
Supplement NumberS094
Date Received03/16/2017
Decision Date03/07/2018
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 order should be issued for the reinforced electrode variant +FLEXSOFT and the Insertion Electrode (IE) variant FLEXSOFT.
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