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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 Starts Clinical Trial For Its Pearl Robotic TMR System

Cardiogenesis is developing a minimally-invasive transmyocardial revascularization (TMR) procedure for use on its Pearl 5.0 robotic laser delivery system, which is expected to receive FDA clearance within a few months

Cardiogenesis Starts Clinical Trial For Its Pearl Robotic TMR System

Cardiogenesis is developing a minimally-invasive transmyocardial revascularization (TMR) procedure for use on its Pearl 5.0 robotic laser delivery system, which is expected to receive FDA clearance within a few months

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...

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