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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.
 
DeviceNeuroform Atlas® Stent System
Generic Nameintracranial coil-assist stent
Applicant
Stryker Neurovascular
47900 bayside parkway
fremont, CA 94538
PMA NumberP180031
Date Received08/15/2018
Decision Date05/16/2019
Product Code QCA 
Docket Number 19M-2408
Notice Date 05/20/2019
Advisory Committee Neurology
Clinical Trials NCT02340585
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approved for use with neurovascular embolization coils in the anterior circulation of the neurovasculature for the endovascular treatment of patients greater or equal to 18 years of age with saccular wide-necked (neck width greater or equal to 4 mm or a dome-to-neck ratio of < 2) intracranial aneurysms arising from a parent vessel with a diameter of greater or equal to 2.0 mm and less than or equal to 4.5 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S002 
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