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Trade Name | NEUROFORM EZ 2 STENT SYSTEM & NEUROFORM EZ 3 STENT SYSTEM ACCESSORY KIT |
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 | S028 |
Date Received | 03/18/2011 |
Decision Date | 05/26/2011 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day 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 for the neuroform ez stent system. The device 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. Wide neck aneurysms are defined as having a neck > 4 mm or a dome-to-neck ratio of < 2. |