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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 NumberS166
Date Received11/18/2024
Decision Date12/18/2024
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  
approval for relocation of a supplier manufacturing facility and manufacturing changes to a surgical tool used with HiRes™ Ultra CI HiFocus™ MS Electrode, HiRes™ Ultra 3D CI HiFocus™ MS Electrode and HiFocus™ Mid-Scala Electrode Insertion Tool Kit
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