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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

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The meeting of the Medical Devices Dispute Resolution Panel scheduled for August 20, 2003, has been cancelled based upon a decision by the sponsor, CardioGenesis Corp., to submit additional data for FDA review in support of their premarket approval application for the Axcis Percutaneous Myocardial Revascularization (PMR).