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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade NameNEUROFORM ATLAS STENT SYSTEM
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Stryker Neurovascular
47900 bayside parkway
fremont, CA 94538
HDE NumberH020002
Supplement NumberS046
Date Received07/01/2015
Decision Date11/02/2017
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Clinical Trials NCT02340585
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
A new stent design and delivery system (i. E. , the neuroform atlas stent system).
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
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