CardioGenesis PMR dispute panel cancelled
This article was originally published in The Gray Sheet
Executive Summary
Interactive review of new data, agreed to by FDA, allows cancellation of planned Aug. 20 medical device dispute resolution panel meeting, according to the firm. The MDDRP was intended to resolve the scientific dispute over CardioGenesis' pending PMA supplement for its PMR percutaneous myocardial revascularization system after FDA deemed the application "not approvable" last December (1"The Gray Sheet" March 3, 2003, p. 3). The MDDRP could be rescheduled if the dispute remains unresolved, the firm says...
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