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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceONYX LIQUID EMBOLIC SYSTEM
Generic NameAgent, injectable, embolic
ApplicantEV3 NEUROVASCULAR
9775 Toledo Way
Irvine, CA 92618
PMA NumberP030004
Date Received03/18/2003
Decision Date07/21/2005
Product Code MFE 
Docket Number 05M-0328
Notice Date 08/22/2005
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE ONYX LIQUID EMBOLIC SYSTEM (LES). THE DEVICE IS INDICATED FOR PRESURGICAL EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 
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