HEART TECHNOLOGY ROTABLATOR PMA: FDA AUDIT OF DATA
This article was originally published in The Gray Sheet
Executive Summary
HEART TECHNOLOGY ROTABLATOR PMA: FDA AUDIT OF DATA at company facilities has been completed, the company says. FDA examined Rotablator premarket approval application documents the weeks of April 4 and April 11 at the company's Bothell, Washington headquarters after uncovering problems with clinical trials of the atherectomy device at the University of California, San Diego.