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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 NumberS043
Date Received07/05/2005
Decision Date12/23/2005
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 PROCESS CONTROL IMPROVEMENTS TO THE HIRES90K COIL-CASE/ELECTRODE SUBASSEMBLY FINAL MOLDING PROCESS. THE PROPOSED CHANGES INCLUDE AN EXTERNAL THERMOCOUPLE TO PROVIDE CLOSED-LOOP CONTROL OF THE MOLD TEMPERATURE, THEREBY PROVIDING BETTER CONTROL OF THE CURING TEMPERATURE OF THE SILICONE, AND BY CONFIGURING THE MOLD TOOL WITH SPRING WASHER (BELLEVILLE WASHERS) TO ALLOW FOR SMOOTHER MOVEMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR INDIVIDUALS AGED 12 MONTHS AND OLDER WITH SEVERE-TO-PROFOUND SENSORINEURAL HEARING LOSS TO RESTORE A LEVEL OF AUDITORY SENSATION VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.
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