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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 pkwy.
fremont, CA 94538
HDE NumberH050001
Supplement NumberS042
Date Received04/06/2012
Decision Date08/08/2012
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 changes to physician and patient labeling for the wingspan stent system with gateway® pta balloon catheter, proposed physician trainingplan, and proposed postmarket surveillance plan. As revised, the wingspan stent system with gateway® pta balloon catheter is indicated "for improving cerebral artery lumen diameter in patients 22 to 80 years old with recurrent (2 or more) strokes refractory to a comprehensive regimen of medical therapy and dueto atherosclerotic disease of intracranial vessels with 70-99% stenosis that are accessible to the system. The most recent stroke must have occurred more than 7 days prior to treatment with the wingspan stent system. Patients are eligible for treatment with the wingspan stent system if their modified rankin score (mrs) is 3 or less at the time of treatment. ".
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