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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 Nameintracranial aneurysm flow diverter
Generic Nameintracranial aneurysm flow diverter
9775 toledo way
irvine, CA 92618
PMA NumberP100018
Date Received05/18/2010
Decision Date04/06/2011
Product Code
OUT[ Registered Establishments with OUT ]
Docket Number 11M-0284
Notice Date 04/20/2011
Advisory Committee Neurology
Clinical Trials NCT00777088
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the pipeline embolization device. This device is indicated for the endovascular treatment of adults (age 22 and above) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 S005 S006 S007 S008 S010 S011 
S012 S013 S014