FDAnews
www.fdanews.com/articles/87923-fda-approves-abiomed-s-ide-for-impella-5-0-minimally-invasive-cardiac-support-systems

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

June 27, 2006

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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