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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.
 
DeviceOnyx™ Liquid Embolic System (LES)
Generic NameAgent, injectable, embolic
ApplicantEv3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
PMA NumberP030004
Supplement NumberS040
Date Received01/30/2026
Decision Date04/29/2026
Product Codes SGU MFE 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the mixing time, packaging configuration, and sterilization process for the Onyx Liquid Embolic System (LES).
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