First FDA device panel of 2005
This article was originally published in The Gray Sheet
Executive Summary
PMA to be reviewed at Circulatory System Devices Panel's Jan. 13 meeting in Gaithersburg, Md. likely is Gore's TAG thoracic endoprosthesis. TAG is an ePTFE graft with self-expanding nitinol support for minimally invasive treatment of thoracic aortic aneurysms. Also at the meeting, the agency will update panelists on the FDA Critical Path initiative [Editors' note: To order a webcast of the meeting, visit "The Gray Sheet" affiliate 1FDAadvisorycommittee.com]....