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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, HIRES ULTRA COCHLEAR IMPLANT WITH THE HIFOCUS MID-SCALA ELECTRODE
Generic Nameimplant, cochlear
Applicant
ADVANCED BIONICS
28515 westinghouse place
valencia, CA 91355
PMA NumberP960058
Supplement NumberS117
Date Received08/03/2015
Decision Date07/15/2016
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 Product No
Approval Order Statement 
Approval Order should be issued for this PMA supplement.
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