FDAnews Device Daily Bulletin

FDA APPROVES ABIOMED'S IDE FOR IMPELLA 5.0 MINIMALLY INVASIVE CARDIAC SUPPORT SYSTEMS

June 28, 2006
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Abiomed, Inc. today announced conditionalapproval by the U.S. Food and Drug Administration (FDA) of itsInvestigational Device Exemption (IDE) for the IMPELLA 5.0 unique,catheter-based Circulatory Support Systems. Clinical trials in theU.S. are to begin immediately.
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