CardioGenesis’ PMR On Deck For FDA Dispute Resolution Panel Review
This article was originally published in The Gray Sheet
Executive Summary
CardioGenesis is retaining Covington & Burling to help prepare for its upcoming dispute resolution panel. The regulatory law firm consulted Lifecore Biomedical in the only other MDDRP review
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CardioGenesis tries again
March meeting will provide another opportunity for firm to present case for PMA approval of PMR percutaneous myocardial revascularization system. FDA deemed the supplemental application "not approvable" in December 2002 (1"The Gray Sheet" March 3, 2003, p. 3). If a "favorable outcome" cannot be reached, CardioGenesis could opt to go before FDA's Medical Devices Dispute Resolution Panel...