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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.
 
DeviceAURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
ADVANCED BIONICS
28515 westinghouse place
valencia, CA 91355
PMA NumberP960058
Supplement NumberS090
Date Received06/09/2011
Decision Date09/12/2011
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO INCREASE THE THICKNESS TO DIELECTRIC LAYERS OF THE SUBSTRATE AND IS INDICATED TO PROVIDE USEFUL HEARING TO INDIVIDUALS WITH SEVERE-TO-PROFOUND SENSORINEURAL HEARING LOSS.
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