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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
Generic NameImplant, cochlear
ApplicantADVANCED BIONICS
28515 WESTINGHOUSE PLACE
VALENCIA, CA 91355
PMA NumberP960058
Supplement NumberS032
Date Received12/09/2003
Decision Date12/16/2003
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN OPTIONAL ACCESSORY ITEM THAT CAN BE USED WITH THE PLATINUM HEADPIECE AND AURIA HEADPIECE. THIS ITEM, NAMED HEADPIECE SPACER, IS A PASSIVE PIECE OF ELASTOMER INTENDED TO BE PLACED BETWEEN THE HEADPIECE INNER SURFACE AND THE PATIENT'S SCALP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12-MONTHS TO 17 YEARS, 11-MONTHS OF AGE).
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