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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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SUI AE and Effectiveness rates


 
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General
Study Status Consolidated
522 Number / Requirement Number PS120091 / PSS001
Date Original Plan Accepted 01/31/2013
Date Current Plan Accepted 08/29/2014
Study Name SUI AE and Effectiveness rates
Device Name Miniarc precise single-incision sling system
Root Document Number K071902 
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The manufacturer has requested to consolidate their multiple 522 orders into one. The original order has been amended to include these devices in one study that will fulfill the 522 order. This device is now included in PS120089..


SUI AE and Effectiveness rates Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/01/2013 08/01/2013 On Time
1 yr report 01/31/2014 02/03/2014 Overdue/Received
18 month report 08/01/2014 08/04/2014 Overdue/Received


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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