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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 MICRODELIVERY STENT SYSTEM
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Stryker Neurovascular
47900 bayside parkway
fremont, CA 94538
HDE NumberH020002
Supplement NumberS022
Date Received08/23/2010
Decision Date09/22/2010
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for updating the labeling with including editorial changes and an updated list of possible adverse events for the neuroform stent. The device, as modified,will be marketed under the trade name neuroform2 and neuroform3 microdelivery stent systems and 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 5 4. 5 mm that are not amendable to treatment with surgical clipping. Wide neck aneurysms are defined as having a neck > 4 mm or a dome-to-neck ratio of < 2.
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