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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.
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