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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-Continued F/u of the Premarket ADO II PAS


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General
Study Status Completed
Application Number P020024 S037/ PAS001
Date Current Protocol Accepted 11/08/2013
Study Name OSB Lead-Continued F/u of the Premarket ADO II PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Design Description To examine the long term safety and effectiveness of the ADO II through continued follow-up of the 178 subjects from the ADO II IDE study in whom device placement has occurred.

Study Population Description Subjects implanted with an ADO II device. No comparison group.
Sample Size A total of 178 subjects were enrolled in the ADO II IDE study and were implanted with the device.

Data Collection The primary ADO II PAS safety objective is to evaluate the rate of device serious adverse events (SAE) reported from the procedure through 5 years post-procedure.

Follow-up Visits and Length of Follow-up 5 years post-procedure - annual visits
Interim or Final Data Summary
Actual Number of Patients Enrolled 178 subjects implanted with the AMPLATZER Duct Occluder II constituted the post-approval study population
Actual Number of Sites Enrolled 25 sites
Patient Follow-up Rate 84.3% (150/178)
Final Safety Findings Freedom from device- and procedure-related serious adverse events through 5 years was 97.9% (95% CI: 94.4 – 99.2).
Final Effect Findings A total of 150 patients had their 60-month visits and 5 did not complete their echocardiograms. The rate of complete closure of the ductus arteriosus at 60 months post-procedure was 100% (145/145).
Study Strengths & Weaknesses The study had a low rate of attrition, thus minimizing selection bias. It also provided results on the long- term (5 years) safety and efficacy of the device. A weakness of this study is that it did not collect data on race and/or ethnicity.
Recommendations for Labeling Changes A labeling change is recommended to add the long-term safety and efficacy results from the pre-market cohort.


OSB Lead-Continued F/u of the Premarket ADO II PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 08/18/2014 08/13/2014 On Time
two year report 08/18/2015 07/30/2015 On Time
Final Report 12/30/2016 02/17/2017 Overdue/Received


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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