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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Classification Nameintracranial neurovascular stent
Generic Nameintracranial neurovascular stent
3200 lakeside dr.
santa clara, CA 95054-2807
HDE NumberH010004
Date Received10/31/2001
Decision Date08/09/2002
Product Code
NJE[ Registered Establishments with NJE ]
Docket Number 02M-0361
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
The neurolink system is indicated for the treatment of patients with recurrent intracranial stroke attributable to atherosclerotic disease refractory to medical therapy in intracranial vessels ranging from 2. 5 to 4. 5 mm in diameter with >/= 50% stenosis and that are accessible to the stent system.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2