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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 NumberS159
Date Received05/09/2023
Decision Date11/17/2023
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) 180-day supplement, which requested approval for a new version of fitting software and a new AB remote support app. Based upon the information submitted, the PMA supplement is approved.
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