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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameagent, injectable, embolic
Generic Nameagent, injectable, embolic
9775 toledo way
irvine, CA 92618
PMA NumberP030004
Supplement NumberS006
Date Received04/22/2013
Decision Date05/27/2014
Product Code
MFE[ Registered Establishments with MFE ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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.