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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 NameWINGSPAN STENT SYSTEM WITH GATEWAY PTA BALLOON CATHETER
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
STRYKER CORP.
47900 bayside parkway
fremont, CA 94538
HDE NumberH050001
Supplement NumberS031
Date Received03/03/2011
Decision Date05/18/2011
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for extension of the shelf life expiration date of the wingspan stent system to 3 years for the wingspan stent system manufactured in cork, irelandand is indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with > 50% stenosis that are accessible to the system.
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