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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.
 
DeviceHARMONY HIRESOLUTION BIONIC EAR SYSTEM
Generic NameImplant, cochlear
ApplicantADVANCED BIONICS
28515 WESTINGHOUSE PLACE
VALENCIA, CA 91355
PMA NumberP960058
Supplement NumberS079
Date Received02/23/2009
Decision Date03/18/2009
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 THE HIRES 90K MOCK-UP AS STERILE INSTEAD OF NON-STERILE, AND TO ESTABLISH THE SHELF LIFE AT THREE YEARS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HARMONY HIRESOLUTION BIONIC EAR SYSTEM HIRES 90K MOCK-UP (MOCK-UP) AND IS INDICATED FOR INDIVIDUALS AGED TWELVE MONTHS AND OLDER WITH SEVERE-TO PROFOUND SENSORINEURAL HEARING LOSS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.
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