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Keyword: drugeluting

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  • FDA Public Health Web Notification {60 deaths from drug eluting stents}

    10/29/2003 3:10:39 PM PST · by Free2Be49 · 8 replies · 245+ views
    US Food and Drug Administration ^ | October 29, 2003 | US Food and Drug Administration
    FDA Public Health Web Notification*:Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Coronary StentIssued 10/29/2003FDA, US Food and Drug Administration  http://www.fda.gov/cdrh/safety/cypher.htmlWhy is the Food and Drug Administration (FDA) issuing this notification?Shortly after the April 24, 2003, approval of the Cordis CYPHER™ Coronary Stent, we began receiving adverse event reports through the Medical Device Reporting (MDR) system. We are still analyzing the information contained in these reports, but wanted to share with you the information we have at this time and encourage you to report your experience (see instructions and links below). What...