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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
PMA NumberP960058
Supplement NumberS149
Date Received05/04/2020
Decision Date12/02/2020
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
Approval Order Statement  
Approval for the New Sound Processors (Naida CI M30, Naida CI M90, and Sky CI M90), New Headpieces (Slim HP, Slim HP AquaMic, Slim HP Mic, and Slim HP Standard), Target CI, AB Remote, and Accessories (M Battery Small, M Battery Medium, M Battery Large, M Standard Battery, M Waterproof Battery, M Zn-Air Battery Pak, M Acoustic Earhook, M Earhook, M T-Mic, Slim HP Standard Magnet, Slim HP 3D Magnet, M Programming Cable, Slim HP Color Cap, and Slim HP Color Cap large).