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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 Ballon Catheter
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
47900 bayside parkway
fremont, CA 94538
HDE NumberH050001
Supplement NumberS085
Date Received07/17/2018
Decision Date08/15/2018
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Updates to the programmable logic controller (plc) software/control system, upgrades to the vacuum pump system, and introduction of parametric release for several ethylene oxide (eo) sterilization chambers at the boston scientific corporation (bsc) coventry, rhode island facility for the gateway pta balloon catheter.