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Review Period Set for Xience Stent System

06/10/2014

Federal Register Notice: FDA has determined the regulatory review period for Abbott Cardiovascular Systems’ Xience Prime Ll Everolimus Eluting Coronary Stent System is 890 days for the purpose of extending a patent which claims the medical device. The Xience system is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length <= 32 mm) with reference vessel diameters of >=2.25 mm to <= 4.25 mm. To view this notice, click here.

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