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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
Applicant
ADVANCED BIONICS
28515 westinghouse place
valencia, CA 91355
PMA NumberP960058
Supplement NumberS131
Date Received09/07/2018
Decision Date08/30/2019
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the HiRes Fidelity 120 and HiRes Optima sound processing strategies for adults and pediatric patients 12 months and older.Approval of the ClearVoice and Front-End Processing features of StereoZoom, UltraZoom, SoundRelax, WindBlock, and EchoBlock for pediatric population 6 years and older.
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