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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.
 
DeviceHARMONY HIRESOLUTION BIONIC EAR SYSTEM
Generic NameImplant, cochlear
ApplicantADVANCED BIONICS
28515 WESTINGHOUSE PLACE
VALENCIA, CA 91355
PMA NumberP960058
Supplement NumberS061
Date Received03/24/2008
Decision Date04/21/2008
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN UPDATED CHANGE TO THE INSTRUCTIONS FOR USE (IFU) FOR THE ICONNECT, AS ACCESSORY TO THE ADVANCED BIONICS BEHIND-THE-EAR SPEECH PROCESSORS, AS FOLLOWS: FROM: ?THE AURIA ICONNECT CAN ONLY USE A STANDARD SIZE 10 BATTERY. DO NOT USE ANY OTHER BATTERY.? TO: ?ONLY ZENIPOWER SIZE 10A BATTERIES FROM ADVANCED BIONICS ARE CERTIFIED FOR USE WITH THE ICONNECT. PLEASE CONTACT ADVANCED BIONICS OF ITS AUTHORIZED DISTRIBUTORS TO PURCHASE THESE BATTERIES. OTHER BATTERIES MAY NOT PROVIDE SUFFICIENT BATTERY LIFE WHEN USED WITH THE ICONNECT.?
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