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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
Generic NameImplant, cochlear
ApplicantADVANCED BIONICS
28515 WESTINGHOUSE PLACE
VALENCIA, CA 91355
PMA NumberP960058
Supplement NumberS089
Date Received06/01/2011
Decision Date11/17/2011
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A NEW OFF-THE-EAR SOUND PROCESSOR CALLED NEPTUNE AND ITS ASSOCIATED ACCESSORIES. THE NEPTUNE PROCESSOR, WHEN USED WITH THE NEW AQUAMIC HEADPIECE, IS WATERPROOF. IN ADDITION, A NEW VERSION OF SOUNDWAVE PROFESSIONAL SOFTWARE SUITE (SOUNDWAVE 2.1) IS INCLUDED IN THE SUPPLEMENT.
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