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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 pkwy.
fremont, CA 94538
HDE NumberH020002
Supplement NumberS023
Date Received09/27/2010
Decision Date10/27/2010
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 revised labeling. The device is indicated for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from aparent vessel with a diameter of> 2 mm and < 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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