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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceSurpass Streamline Flow Diverter
Generic NameIntracranial aneurysm flow diverter
ApplicantStryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538
PMA NumberP170024
Date Received07/31/2017
Decision Date07/13/2018
Product Code OUT 
Docket Number 18M-2884
Notice Date 07/26/2018
Advisory Committee Neurology
Clinical TrialsNCT01716117
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for The Surpass Streamline Flow Diverter. The Surpass Streamline Flow Diverter is indicated for use in the endovascular treatment of patients (18 years of age and older) with unruptured large or giant saccular wide-neck (neck width >= 4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter >= 2.5 mm and <= 5.3 mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011