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Trade Name | NEUROFORM EZ 2 STENT SYSTEM & NEUROFORM EZ 3 STENT SYSTEM ACCESSORY KIT |
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 | S025 |
Date Received | 12/06/2010 |
Decision Date | 06/10/2011 |
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 |