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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.
 
DeviceHIRESOLUTION BIONIC EAR SYSTEM
Generic NameImplant, cochlear
ApplicantADVANCED BIONICS
28515 WESTINGHOUSE PLACE
VALENCIA, CA 91355
PMA NumberP960058
Supplement NumberS108
Date Received02/14/2014
Decision Date07/29/2014
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 CONCAVE UNIVERSAL HEAD PIECE, A REDESIGNED VERSION OF THE CURRENT UNIVERSAL HEAD PIECE. THE CONCAVE UNIVERSAL HEAD PIECE SUPPORTS BOTH BEHIND THE EARAND BODY WORN SOUND PROCESSORS AND IS INTENDED FOR INCREASE OF WEARING COMFORT FOR THE HIRES90K ADVANTAGE IMPLANT USERS.
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