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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.
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Stryker Neurovascular
47900 bayside parkway
fremont, CA 94538
HDE NumberH020002
Supplement NumberS044
Date Received07/15/2014
Decision Date09/11/2016
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its review of your humanitarian device exemption (hde) 75-day supplement, which requested approval for a change to the green colorant in the polytetrafluoroethylene (ptfe) coating of the stent delivery wire (sdw) subassembly for the the neuroform ez® 3 stent system, elimination of the use of perfluorooctanoic acid (pfoa) as a processing aid in the manufacture of ptfe, and to respond to deficiency #1 from the february 13, 2015 letter.