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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 NameCORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
Medos International, SARL
chemin-blanc 38
le locle 2400
HDE NumberH060001
Supplement NumberS007
Date Received04/02/2008
Decision Date05/02/2008
Product Code
NJE[ Registered Establishments with NJE ]
Advisory Committee Neurology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the addition to the product label of a precaution statement regarding the risk of thrombosis in patients in whom antiplatelet and anticoagulant therapies arecontraindicated, and the antiplatelet and anticoagulant medical therapy regimen used during the clinical evaluation of the device.
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