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Ophthalmic Devices Panel

This article was originally published in The Gray Sheet

Executive Summary

Premarket approval application for Vision Correction Group's Emory System of LASIK laser in-situ keratomileusis (LASIK) for treatment of myopia is scheduled for discussion June 5 in Rockville, Maryland. On July 11, 1997, FDA's Ophthalmic Devices Committee recommended that VCG's LASIK PMA be approved, but asked that more thorough follow-up data be obtained using a revised patient questionnaire ("The Gray Sheet" July 21, 1997, p. 10)



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