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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 NumberS087
Date Received10/22/2010
Decision Date12/14/2010
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A NEW VERSION OF HEADPIECE, CALLED THE UNIVERSAL HEADPIECE (UHP). THIS CHANGE IS BEING MADE TO PROVIDE A SINGLE HEADPIECE THAT CAN BE USED UNIVERSALLY WITH THE BODY-WORN AND BEHIND-THE-EAR SOUND PROCESSORS AS PART OF A COCHLEAR IMPLANT SYSTEM.
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