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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.
 
DeviceHARMONY HIRESOLUTION BIONIC EAR SYSTEM
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
ADVANCED BIONICS
28515 westinghouse place
valencia, CA 91355
PMA NumberP960058
Supplement NumberS092
Date Received10/03/2011
Decision Date10/26/2011
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the manufacturing process to improve an insertion tool and to document a change in the tool suppliers.
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