CardioGenesis tries again
This article was originally published in The Gray Sheet
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...
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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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