SUMMIT TECHNOLOGY PRK INVESTIGATOR DISCONTINUING PROMOTIONAL LITERATURE
This article was originally published in The Gray Sheet
SUMMIT TECHNOLOGY PRK INVESTIGATOR DISCONTINUING PROMOTIONAL LITERATURE following an FDA warning letter objecting to the investigator's brochures and pamphlets promoting excimer laser surgery for photorefractive keratectomy (PRK). FDA says the promotional material violates the Federal Food, Drug, and Cosmetic Act "since the investigational device is being represented as safe and effective for the purpose for which it is being studied."
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