Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair

Name: Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair
Creator: Food and Drug Administration
Keywords: applications,approval,fda,inspection,mesh,notices,organs,pma,pre-market,pre-market-approval,pre-market-authorization,requirements,rules,surgical,surgical-mesh

Information

Type

Rule

Regulated products

Published

January 5, 2016

Last updated

January 5, 2016

Description

Document number 2015-33163. 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.

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Food and Drug Administration (FDA) 🇺🇸

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United States

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Other (Public Domain)

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Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair

Updated on January 5, 2016

html

URL: https://www.federalregister.gov/documents/2016/01/05/2015-33163/effective-date-of-requirement-for-premarket-approval-for-surgical-mesh-for-transvaginal-pelvic-organ
Permalink: https://data.openrid.co/en/datasets/r/065a63e7-762e-4ddb-b02e-6592b632a915
MIME Type: text/html

Created on: January 5, 2016
Modified on: January 5, 2016

Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair

Updated on January 5, 2016

pdf

URL: https://www.govinfo.gov/content/pkg/FR-2016-01-05/pdf/2015-33163.pdf
Permalink: https://data.openrid.co/en/datasets/r/8852c2f9-73c4-4dc8-b457-6db95a4f72e9
MIME Type: application/pdf

Created on: January 5, 2016
Modified on: January 5, 2016

Public Inspection: Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair

Updated on January 5, 2016

pdf

URL: https://public-inspection.federalregister.gov/2015-33163.pdf?1451915188
Permalink: https://data.openrid.co/en/datasets/r/1b1f5ec7-9995-4c9d-8f10-1fe17e6e1e07
MIME Type: application/pdf

Created on: January 5, 2016
Modified on: January 5, 2016

Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair

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