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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 NumberS006
Date Received03/30/2007
Decision Date04/20/2007
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typespecial (immediate track)
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for addition of a visual inspection criteria to ensure quality assurance of the wingspan stent marker bands.
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