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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 | S029 |
Date Received | 12/10/2010 |
Decision Date | 08/12/2011 |
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 changing the fabrication procedure and tolerances for the strain relief of the gateway pta balloon catheter and is indicated for improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with greater than or equal to 50% stei1osis that are accessible to the system. |