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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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POP AE and Effectiveness rates, registry

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Study Status Progress Adequate
522 Number / Requirement Number PS130044 / PSS001
Date Current Plan Accepted 04/06/2018
Study Name POP AE and Effectiveness rates, registry
Root Document Number K122459 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Non-randomized, parallel cohort, multi-center study using PFD Registry.
Study Population Description This study will enroll adult (= 18), non-pregnant women who have been diagnosed with anterior and/or apical pelvic organprolapse and will undergo repair surgery, and who mayor may not also undergo a concomitant procedure (such as an anterior repair, posterior repair, hysterectomy, or sling placement for stress urinary incontinence).

If a concomitant procedure were to occur, the sling placement should be a synthetic material, however the concomitant anterior or posterior repair cannot include a mesh implant. An anterior colporrhaphy maybe performed for cystocele repair, if clinically necessary.

Sample Size Approximately 414 subjects (207 subjects per arm) from up to 40 study centers in the United States will be enrolled. Eligible number of control subjects meeting the study inclusion/exclusion criteria may be shared from the PFD Registry.

Data Collection Enrollment: Subjects will be considered enrolled in the study once an incision is made in the vaginal wall. All enrolled subjects will have been consented and assigned to receive either the treatment or control procedure per site assignment. All enrolled subjects with a surgery initiated (i.e. incision in vagina) will be considered part of the Intent-to-Treat (ITT) population for the final study analysis. All eligible ITT subjects enrolled who undergo the assigned study procedure and had no major protocol deviations will be considered part of the Per Protocol analysis.

Follow-up Visits and Length of Follow-up The length of follow-up is 3 years. Data will be collected following the procedure at 6, 12, 18, 24, and 36 months.

POP AE and Effectiveness rates, registry Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 Month Report 03/12/2014 03/24/2014 Overdue/Received
1 Year Report 09/11/2014 09/10/2014 On Time
18 month report 03/12/2015 03/12/2015 On Time
2 Year Report 09/11/2015 09/10/2015 On Time
3 Year Report 09/10/2016 09/09/2016 On Time
4 yr report 09/10/2017 09/08/2017 On Time
5 yr report 09/10/2018 09/12/2018 Overdue/Received
Unsolicited report 01/11/2019 01/11/2019 On Time
6 year report 09/13/2019 09/13/2019 On Time
Final report 06/17/2020 11/02/2020 Overdue/Received