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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameagent, injectable, embolic
Generic Nameonyx 18/onyx 34
PMA NumberP030004
Date Received03/18/2003
Decision Date07/21/2005
Product Code
MFE[ Registered Establishments with MFE ]
Docket Number 05M-0328
Notice Date 08/22/2005
Advisory Committee Neurology
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the onyx liquid embolic system (les). The device is indicated for presurgical embolization of brain arteriovenous malformations.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S005 S006 S007 S008