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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 | S003 |
Date Received | 03/24/2003 |
Decision Date | 04/30/2003 |
Product Code | |
Docket Number | 02M-0409 |
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 a design change to the 2f stabilizer catheter. The design change involves a 1 -piece molded proximal section (i. E. , luer hub/strain relief/proximaltubing) from a new component supplier. |