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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 NumberS025
Date Received08/31/2010
Decision Date09/24/2010
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 for the wingspan® stent system.
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