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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 NumberS083
Date Received11/13/2017
Decision Date12/12/2017
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 
To sterilize the gateway pta balloon catheter with the optimized bsc2000-2 ethylene oxide cycle in chambers 1, 2, 3, 5, 6, 7, 8, 9 and 10 at bsc coventry, rhode island.
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