federal_register: 2014-09909

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2014-09909 Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair Proposed Rule The Food and Drug Administration (FDA or the Agency) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) if the surgical mesh for transvaginal pelvic organ prolapse (POP) repair device is reclassified from class II to class III. The Agency is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's PMA requirements and the benefit to the public from the use of the device. 2014-05-01 2014 5 https://www.federalregister.gov/documents/2014/05/01/2014-09909/effective-date-of-requirement-for-premarket-approval-for-surgical-mesh-for-transvaginal-pelvic-organ https://www.govinfo.gov/content/pkg/FR-2014-05-01/pdf/2014-09909.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) if the surgical mesh for transvaginal pelvic organ prolapse (POP) repair device is...

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