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Summit Technology

This article was originally published in The Gray Sheet

Executive Summary

Plans to submit in January 1995 additional data on the premarket approval application for its Omnimed excimer laser for the treatment of myopic photorefractive keratectomy. The Waltham, Massachusetts-based firm says it received "written clarification" Dec. 12 from FDA regarding additional data requirements for the device's approval following review of the PMA by the agency's Ophthalmic Devices Panel on Oct. 20. The panel voted 13-1 to recommend approval of Summit's PRK laser contingent upon Summit providing additional information, including data on: redevelopment of corneal endothelium after surgery, quality control and reliability of the system, and best corrected visual acuity ("The Gray Sheet" Oct. 24, p. 3)
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