CardioGenesis gets “interactive”
This article was originally published in The Gray Sheet
Executive Summary
Special FDA review of additional Axcis percutaneous myocardial revascularization system data supplied by the company will take "about eight to 10 weeks," the firm says Aug. 28. FDA deemed the device "not approvable" last December; a subsequent medical device dispute resolution panel was cancelled after the agency agreed to review additional data (1"The Gray Sheet" July 21, 2003, In Brief)...