SUMMIT'S OMNIMED EXCIMER LASER APPROVABLE CONTINGENT ON SUBMISSION OF ADDITIONAL DATA, PANEL RECOMMENDS; COMPANY EXPECTS APPROVAL BY END OF 1995
This article was originally published in The Gray Sheet
Executive Summary
Summit Technology's OmniMed excimer laser should be approved by FDA for treating nearsightedness with photorefractive keratectomy as long as the company can meet a number of additional requirements, the agency's Ophthalmic Devices Panel recommended in a 13-1 vote at an Oct. 20 meeting in Gaithersburg, Maryland.