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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.
 
DeviceHIRESOLUTION BIONIC EAR SYSTEM
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
ADVANCED BIONICS
28515 westinghouse place
valencia, CA 91355
PMA NumberP960058
Supplement NumberS095
Date Received12/30/2011
Decision Date06/15/2012
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ADVANCED BIONICS, LLC AND A FINISHED GOODS WAREHOUSE LOCATED IN VALENCIA, CALIFORNIA.
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