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FDA Approvals - FDA Approves Expansion of Cardiovascular Systems Inc. Clinical Trial of


FDA Approves Expansion of Cardiovascular Systems Inc. Clinical Trial of the Orbital Atherectomy System for Treatment of (RedNova)
ST. PAUL, Minn., July 19 /PRNewswire/ -- Cardiovascular Systems, Inc. (CSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the expansion of the OASIS clinical trial following review of the safety data from the feasibility phase of the study.

AtriCure Receives FDA 510(k) Clearance for Multifunctional Isolator(TM) Transpolar (TM) Pen System and Releases New (PR Newswire via Yahoo! Finance)
AtriCure, Inc. , a medical device company focused on developing, manufacturing and selling innovative surgical devices, announced today that it has received Food and Drug Administration 510 clearance for its Isolator Transpolar Pen System for pacing, sensing, stimulating, and recording during the evaluation of cardiac arrhythmias in addition to its currently FDA- cleared use for the ablation of
 

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