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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 NameNEUROFORM2 AND NEUROFORM3 MICRODELIVERY STENT SYSTEMS
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Stryker Neurovascular
47900 bayside parkway
fremont, CA 94538
HDE NumberH020002
Supplement NumberS016
Date Received01/28/2009
Decision Date05/27/2010
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 
Approval for adding another delivery system (a guidewire delivery) for the neuroform2 (2-interconnect stent) and neuroform3 (3-interconnect stent) stents. Theadditional devices will be marketed under the trade names neuroform ez 2 and neuroform ez 3 stent systems. Each neuroform stent system is indicated for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of> 2 mm and < 4. 5 mm that are not amendable to treatment with surgical clipping. Xwide neck aneurysms are defined as having a neck > 4 mm or a dome-to-neck ratio of < 2:.
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