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Trade Name | NEUROFORM MICRODELIVERY STENT |
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 | S005 |
Date Received | 06/12/2003 |
Decision Date | 07/14/2003 |
Product Code | |
Docket Number | 02M-0409 |
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 revised labeling based on a system name change. The system will be now marketed under the trade name neurofomntm2 microdelivery stent system. |