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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
Generic NameAgent, injectable, embolic
ApplicantEv3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
PMA NumberP030004
Supplement NumberS003
Date Received09/24/2007
Decision Date10/09/2007
Product Code MFE 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REVISION OF THE PRODUCT LABEL TO INCLUDE A BOXED WARNING REGARDING THE EMISSION OF SPARKS THAT OCCURS WHEN ONYX-EMBOLIZED TISSUE IS SURGICALLY RESECTED WITH MONOPOLAR ELECTROCAUTERY DEVICES.
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