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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS091
Date Received09/30/2011
Decision Date04/27/2012
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
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 be marketed 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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