Summit Technology
This article was originally published in The Gray Sheet
Executive Summary
Submits patient followup data to FDA on March 31 which Summit believes places its excimer laser phototherapeutic keratectomy (PTK) PMA application "in an approvable form." On March 21, FDA's Ophthalmic Devices Advisory Panel recommended approval of the device contingent upon the submission of one-year followup data covering safety, efficacy and stability of the laser application ("The Gray Sheet" March 28, 1994, p. 13)