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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCODMAN ENTERPRISE VASCULAR RECONSTRUCTIVE DEVICE AND DELIVERY SYSTEM
Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
Applicant
CODMAN & SHURTLEFF, INC.
325 paramount dr.
raynham, MA 02767-0350
HDE NumberH060001
Date Received02/17/2006
Decision Date05/08/2007
Product Code
NJE[ Registered Establishments with NJE ]
Docket Number 07M-1090
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the cordis enterprise vascular reconstruction device and delivery system. This device is intended for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of> 3 mm and < 4 mm. Wide-neck is defined as having a neck width > 4mm or a dome-to-neck ratio < 2.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
S011 S012 S014 S015 S016 S017 S018 
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