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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Enhanced Surveillance

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Study Status Completed
Application Number P040050 / PAS002
Date Current Protocol Accepted 10/30/2006
Study Name OSB Lead-Enhanced Surveillance
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Enhanced surveillance to rapidly assess potential adverse events related to the use of Macroplastique following its launch in the U.S. marketplace. It involved the active solicitation of information on adverse events associated with Macroplastique from all U.S. physician customers on a quarterly basis for two years following PMA approval.
Study Population Description All patients receiving the device. The device is indicated for women who have stress urinary incontinence due to poorly functioning urethral sphincter muscles.
Sample Size N/A
Data Collection Information on patient characteristics, treatment and retreatment, and onset, severity, and resolution of the event are to be obtained only if the customers have reportable events.
Follow-up Visits and Length of Follow-up N/A
Interim or Final Data Summary
Interim Safety Information Study completed, see final results
Actual Number of Patients Enrolled N/A
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate 87%
Final Safety Findings No serious adverse events were identified by the Enhanced Surveillance Program since device was launched to market in the U.S through March 2008. The data for enhanced surveillance was collected for 2 years as per approval order.
Study Strengths & Weaknesses Enhanced surveillance system with high response rate from participating physicians.
Recommendations for Labeling Changes Update labeling to reflect the results of the Post-Approval Study

OSB Lead-Enhanced Surveillance Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year enhanced surveillance report 10/30/2007 11/01/2007 Overdue/Received
18 month enhanced surveillance report 04/29/2008 04/29/2008 On Time
2 year enhanced surveillance report 10/29/2008 10/29/2008 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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