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Trade Name | WINGSPAN STENT SYSTEM WITH GATEWAY PTA BALLOON CATHETER |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
STRYKER CORP. |
47900 bayside parkway |
fremont, CA 94538 |
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HDE Number | H050001 |
Supplement Number | S042 |
Date Received | 04/06/2012 |
Decision Date | 08/08/2012 |
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 changes to physician and patient labeling for the wingspan stent system with gateway® pta balloon catheter, proposed physician trainingplan, and proposed postmarket surveillance plan. As revised, the wingspan stent system with gateway® pta balloon catheter is indicated "for improving cerebral artery lumen diameter in patients 22 to 80 years old with recurrent (2 or more) strokes refractory to a comprehensive regimen of medical therapy and dueto atherosclerotic disease of intracranial vessels with 70-99% stenosis that are accessible to the system. The most recent stroke must have occurred more than 7 days prior to treatment with the wingspan stent system. Patients are eligible for treatment with the wingspan stent system if their modified rankin score (mrs) is 3 or less at the time of treatment. ". |