Impra vascular graft tracking variance request needs clarification, FDA says.
This article was originally published in The Gray Sheet
Executive Summary
IMPRA'S ALTERNATE PROCEDURES FOR TRACKING VASCULAR GRAFTS need clarification before FDA can approve them, the agency says in a recent response to an Impra petition filed in March 1994. FDA informs the company that "the agency has been unable, thus far, to determine whether it should grant the tracking variance requested in the petition, due to the need for the firm to provide and clarify certain information."