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 | AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S091 |
Date Received | 09/30/2011 |
Decision Date | 04/27/2012 |
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 |
Approval Order Statement APPROVAL OF DESIGN CHANGES IMPLEMENTED IN THE APPROVED HIRES 90K COCHLEAR IMPLANT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME "HIRES+90KR ADVANTAGE", HEREAFTER REFERRED TO AS "ADVANTAGE." THIS MODIFIED COCHLEAR IMPLANT DESIGN WILL BEMARKETED UNDER A NEW MODEL NUMBER (CI-1500-XXX) AND THE BRAND NAME FOR THE HIRES 90K COCHLEAR IMPLANT, "AURIA HARMONY HIRCSOLUTION BIONIC EAR SYSTEM" WILL BE CHANGED TO "HIRESOLUTION BIONIC EAR SYSTEM." THE ADVANTAGE IMPLANT INCLUDES THE FOLLOWING: A REINFORCED ANTENNA COIL AND AN INTEGRATED SILICONS POCKET FOR THE MAGNET. THE IMPLANT DIGITAL INTEGRATED CIRCUIT HAS ALSO BEEN REVISED TO INCLUDE THE LATEST WAFER ASSEMBLY PROCESSES. |
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