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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 NameGATEWAY PTA BALLOON CATHETER
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
STRYKER CORP.
47900 bayside parkway
fremont, CA 94538
HDE NumberH050001
Supplement NumberS049
Date Received11/20/2012
Decision Date05/23/2013
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for a change in the method of product preparation for wingspan stent system endotoxin testing.
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