Emory researchers' LASIK PMA is approvable, but more data needed -- FDA panel.
This article was originally published in The Gray Sheet
Executive Summary
EMORY LASIK PMA IS APPROVABLE, BUT NEEDS TO RETURN TO PANEL with further data analysis and additional data from an ongoing Group 2 trial, FDA's Ophthalmic Devices Panel concluded at a July 11 meeting in Gaithersburg, Maryland.