PMA - Premarket Approval

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New Search Back to Search Results Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.   Trade Name XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM Classification Name coronary drug-eluting stent Generic Name drug eluting coronary stent system Applicant ABBOTT VASCULAR INC. PMA Number P070015 Date Received 06/01/2007 Decision Date 07/02/2008 Product Code NIQ [ Registered Establishments with NIQ ] Docket Number 08M-0535 Notice Date 10/07/2008 Advisory Committee Cardiovascular Expedited Review Granted? No Information About: Labeling, Approval Order, Summary of Safety and Effectiveness Approval Order Statement  Approval for the xience v everolimus eluting coronary stent system, which will also be distributed as the promus everolimus eluting coronary stent system. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length <= 28 mm) with reference vessel diameters of 2. 5 mm to 4. 25 mm. Post-Approval Study Show Report Schedule and Study Progress Supplements: S001 S002 S003 S004 S005 S006  S007 S008 S010 S011 S012 S013  S014 S015 S016 S017 S018 S019  S020 S021 S023 S024 S025 S026