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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 NumberS092
Date Received05/24/2019
Decision Date08/10/2019
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 to update the directions for use (dfu) to include the results and design of the section 522 postmarket surveillance study titled “wingspan stent system post market surveillance (weave)” for the wingspan stent system with gateway pta balloon catheter. Additionally, a new black box warning has been added to the dfu to warn practitioners of the higher risk of stroke or death when the device is used outside of the fda-approved indications for use.
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