f Post-Approval Studies (PAS) Database
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
  • Print
  • Share
  • E-mail
-

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.

Learn more...


           

Continued F/u of the Premarket ADO II PAS


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Completed
Application Number /
Requirement Number		 P020024 S037/ PAS001
Date Original Protocol Accepted 08/18/2013
Date Current Protocol Accepted 11/08/2013
Study Name Continued F/u of the Premarket ADO II PAS
Device Name AMPLATZER DUCT OCCLUDER II
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 Objectives 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 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.
Key Study Endpoints 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.


Continued F/u of the Premarket ADO II PAS Reporting Schedule

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

Additional Resources

-
-