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Trade Name | NEUROFORM2 AND NEUROFORM3 MICRODELIVERY STENT SYSTEMS |
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 | S018 |
Date Received | 12/07/2009 |
Decision Date | 05/14/2010 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to the attachment process for a component of the neuroform microdelivery stent system. |