PMA Mandate Set For Pelvic Organ Prolapse Transvaginal Mesh
This article was originally published in Clinica
Existing manufacturers of transvaginal surgical mesh for pelvic organ prolapse procedures, including Boston Scientific Corp., ACell Inc., Coloplast AS, and American Medical Systems Holdings Inc., will have to file for PMAs in 30 months to keep their mesh products on the markets, says FDA in a Jan. 4 final order.
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