
Home » MEDICALCV, SUBMITS 510(K) APPLICATION TO FDA FOR ATRILAZE MINIMALLY INVASIVE SYSTEM
MEDICALCV, SUBMITS 510(K) APPLICATION TO FDA FOR ATRILAZE MINIMALLY INVASIVE SYSTEM
June 1, 2006
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)
KEYWORDS FDAnews Device Daily Bulletin
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