Cook Medical Submits Final PMA Modules to FDA for Approval of the Cook Zenith TX2(R) Thoracic Aortic Aneurysm Endovascular Graft
8/8/2007 11:37:47 AM
Cook Medical has submitted the final module of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Cook Zenith TX2® Thoracic Aortic Aneurysm (TAA) Endovascular Graft. Cook’s PMA application includes safety and effectiveness data on approximately 230 patients who have been treated with the Cook Zenith TX2 in clinical trials at 42 sites across North America and Europe.
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