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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 NumberS010
Date Received06/28/2010
Decision Date08/16/2010
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 to revise an existing statement in the precaution section and move it to the warning section of the labeling.
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