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Trade Name | NEUROFORM MICRODELIVERY STENT SYSTEM |
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 | S032 |
Date Received | 10/24/2012 |
Decision Date | 11/28/2012 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updating the labeling on nickel allergies, mri compatibility, and adverse events. The neuroform microdelivery stent system is indicated foruse 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 surgical clipping. Wide-necked aneurysms are defined as having a neck > 4 mm or a dome to neck ration of < 2. |