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In Brief: Summit Technology

This article was originally published in The Gray Sheet

Executive Summary

Summit Technology: Summary of safety and effectiveness data for Summit's SVS Apex excimer laser PMA is available through FDA's Dockets Management Branch, according to an Aug. 15 Federal Register notice. A premarket approval application for the laser's use in photorefractive keratectomy received FDA approval Oct. 20, 1995. Publication of the summary allows for submission of petitions challenging the approval. FDA has said it expects the Summit PMA, as well as Visx's PMA for its Star PRK laser to be challenged. For more information, contact Debra Lewis, head of the Center for Devices and Radiological Health's Staff College, at 301/827-3623...

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