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Trade Name | NEUROLINK SYSTEM |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
ABBOTT VASCULAR-CARDIAC THERAPIES |
3200 lakeside dr. |
santa clara, CA 95054-2807 |
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HDE Number | H010004 |
Date Received | 10/31/2001 |
Decision Date | 08/09/2002 |
Product Code | |
Docket Number | 02M-0361 |
Advisory Committee |
Neurology |
Supplement Type | hde original |
Expedited Review Granted? | No |
Combination Product | No |
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 |