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FDA Sets Review Period for Xience Stent System

04/29/2015

Federal Register Notice: FDA has determined the regulatory review period for Abbott Cardiovascular Systems’ Xience Xpedition Everolimus Eluting Coronary Stent System is 178 days for extending a patent which claims that medical device. The Xience system is indicated for improving coronary luminal diameter in subjects with symptomatic heart disease due to de novo native coronary artery lesions (length <=32 mm) with reference vessel diameter of >=2.25 mm and <=4.25 mm. To view this notice, click here.

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