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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 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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