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Trade Name | NEUROFORM EZ STENT SYSTEM |
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 | S044 |
Date Received | 07/15/2014 |
Decision Date | 09/11/2016 |
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 The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its review of your humanitarian device exemption (hde) 75-day supplement, which requested approval for a change to the green colorant in the polytetrafluoroethylene (ptfe) coating of the stent delivery wire (sdw) subassembly for the the neuroform ez® 3 stent system, elimination of the use of perfluorooctanoic acid (pfoa) as a processing aid in the manufacture of ptfe, and to respond to deficiency #1 from the february 13, 2015 letter. |