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Boston Scientific’s Taxus Liberte

This article was originally published in The Gray Sheet

Executive Summary

Second-generation paclitaxel-eluting coronary stent system gets FDA "approvable" letter. Boston Scientific plans to launch the device soon after FDA lifts restrictions imposed by a 2006 corporate warning letter citing quality system violations. FDA is re-inspecting the firm's manufacturing facilities and the company expects the restrictions to be lifted around mid-year (1"The Gray Sheet" Feb. 11, 2008, p. 11)

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