title: Effective Date of Requirement for Premarket Approval for Surgical   Mesh for Transvaginal Pelvic Organ Prolapse Repair. Final order.
abstract: The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse (POP) repair.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification; D005260:Female; D006801:Humans; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D013526:Surgical Mesh / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration