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FDA Moves To Require Premarket Approval For Vaginal Mesh

By Kira Lerner ( April 29, 2014, 12:56 PM EDT) -- The U.S. Food and Drug Administration on Tuesday issued two proposed orders that would reclassify surgical mesh for transvaginal repair of pelvic organ prolapse as a high-risk device and would require manufacturers to apply for premarket approval with the agency....

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