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FDA panel to review Medtronic's Endeavor stent PMA (pre-market approval) in October:

This article was originally published in Clinica

Executive Summary

An advisory panel from the US FDA is to convene in October in order to review the pre-market approval (PMA) application for Medtronic's Endeavor stent. The agency will announce the date and agenda for the meeting four to six weeks in advance. The PMA application was submitted last November, and was expected to be approved in mid-2007. The Minneapolis, Minnesota-based firm has now altered this expectation; Scott Ward, president of the cardiovascular business at Medtronic, said that approval was anticipated later this calendar year. Analyst Glenn Reicin, however, has described this expectation as an example of "perpetual overoptimism"; there is "no way" the FDA will approve it before 2008, he told the New York Times. The device was CE marked in 2005.






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