Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NameNeurovascular Liquid Embolic Agent
ApplicantEv3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
PMA NumberP030004
Supplement NumberS035
Date Received10/15/2024
Decision Date12/08/2025
Product Code SGU 
Advisory Committee Neurology
Clinical TrialsNCT04402632
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Onyx Liquid Embolic System (LES) is indicated for embolization of the middle meningeal artery (MMA) as an adjunct to surgery for the treatment of symptomatic subacute or chronic subdural hematoma (SDH).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
-
-