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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 Pl.
Valencia, CA 91355
PMA NumberP960058
Supplement NumberS172
Date Received09/15/2025
Decision Date10/14/2025
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a replacement material resin for sound processor programming cables, connector housings, and a battery cap
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