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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 | S023 |
Date Received | 09/27/2010 |
Decision Date | 10/27/2010 |
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 revised labeling. The device is indicated for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from aparent vessel with a diameter of> 2 mm and < 4. 5 mm that are not amendable to treatment with surgical clipping. Wide neck aneurysms are defined as having a neck > 4 mm or a dome-to-neck ratio of< 2. |