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In Brief: FDA Ophthalmic Devices Advisory Panel

This article was originally published in The Gray Sheet

Executive Summary

FDA Ophthalmic Devices Advisory Panel: Premarket approval application supplement supporting use of Visx' Star excimer laser to treat myopic astigmatism slated for review by the panel at a Jan. 14, 1997 meeting. Visx' supplement seeks approval to treat myopia of -1 to -6 diopters with astigmatism of -0.75 to -4.5 diopters. The firm's current approval covers myopia of -1 to -6 diopters with astigmatism of -1 diopter or less. On Jan. 13, review of a PMA for a retinal tamponade is on the panel's agenda...
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