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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 NumberS165
Date Received05/22/2024
Decision Date01/29/2025
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a manufacturing site located at:Advanced Bionics North America Operations CenterAvenida Riba 875Parque Industrial Condesa 21395Mexicali, Baja California Mexico;for assembly of the Naida M and Naida Q sound processors at the semi-finished goods level.
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