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CardioGenesis Percutaneous Myocardial Revascularization (PMR) System Scheduled for Review by FDA Panel on August 20; Independent Panel of Experts Will Make Recommendation to FDA on PMR Supplemental Premarket Approval Application.

Publication: PR Newswire
Publication Date: 29-MAY-03 		Format: Online
Delivery: Immediate Online Access

Article Excerpt
CardioGenesis Corporation (BULLETIN BOARD: CGCP) , the worldwide leader in angina- relieving Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Revascularization (PMR), today announced that an independent panel of scientific experts of the U.S. Food and Drug Administration (FDA) is now scheduled to meet on August 20 to review scientific data and make recommendations to resolve the dispute over the Company's supplemental Premarket Approval (PMA) application for the PMR system.

The review will be conducted by the FDA's Medical Devices Dispute Resolution Panel (MDDRP), a group of independent experts authorized to review and make findings and recommendations concerning scientific disputes between an applicant and the FDA. The panel will make a recommendation to the Director...

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