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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 NumberS006
Date Received04/22/2013
Decision Date05/27/2014
Product Code MFE 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE APOLLO ONYX DELIVERY MICRO CATHETER THAT WILL BE MANUFACTURED AT MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR IN IRVINE, CALIFORNIA.
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