FDAnews Device Daily Bulletin

MEDICALCV, SUBMITS 510(K) APPLICATION TO FDA FOR ATRILAZE MINIMALLY INVASIVE SYSTEM

June 2, 2006
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MedicalCV, Inc., announced today that it has submitted a 510(k) application to the United States Food and Drug Administration (FDA). The application seeks marketing clearance for the ATRILAZE Minimally Invasive System, a laser-based system specifically designed to enable access to and ablation of cardiac tissue for the potential treatment of atrial fibrillation (AF) in a closed-chest beating heart setting. Business Wire (http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20060531005320&newsLang=en)