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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.
 
DeviceCLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE
Generic NameImplant, cochlear
ApplicantADVANCED BIONICS
28515 WESTINGHOUSE PLACE
VALENCIA, CA 91355
PMA NumberP960058
Supplement NumberS028
Date Received11/01/2002
Decision Date11/25/2002
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MINOR CHANGES TO THE HIFOCUS ELECTRODE TO BETTER FACILITATE THE PACKING OF THE COCHLEOSTOMY AND ELECTRODE INSERTION. SPECIFICALLY, THE CHANGES ARE TO MOVE THE OFFSET REGION APPROXIMATELY 3 MM FURTHER AWAY FROM THE CURRENT LOCATION.
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