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Trade Name | NEUROFORM2 AND NEUROFORM3 MICRODELIVERY STENT SYSTEMS |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
Stryker Neurovascular |
47900 bayside parkway |
fremont, CA 94538 |
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HDE Number | H020002 |
Supplement Number | S016 |
Date Received | 01/28/2009 |
Decision Date | 05/27/2010 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding another delivery system (a guidewire delivery) for the neuroform2 (2-interconnect stent) and neuroform3 (3-interconnect stent) stents. Theadditional devices will be marketed under the trade names neuroform ez 2 and neuroform ez 3 stent systems. Each neuroform stent system is indicated for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of> 2 mm and < 4. 5 mm that are not amendable to treatment with surgical clipping. Xwide neck aneurysms are defined as having a neck > 4 mm or a dome-to-neck ratio of < 2:. |