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. |
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Device | HIRESOLUTION BIONIC EAR SYSTEM |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S043 |
Date Received | 07/05/2005 |
Decision Date | 12/23/2005 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
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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