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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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Long Term F/U Study

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Study Status Progress Adequate
Application Number P020018 S040/ PAS001
Date Current Protocol Accepted 12/12/2012
Study Name Long Term F/U Study
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Observational, single-arm, multi-center, prospective cohort study
Study Population Description Subjects from the pivotal trial plus at least 20 new subjects
Sample Size 88
Data Collection Primary endpoint: 5-year aneurysm-related mortality rate;

Secondary endpoints: Aneurysm rupture, conversion to open surgery, device integrity, device patency, change in aneurysm size, endoleak, device migration, secondary interventions, and morbidity index, defined as the percent of patients who have one or more specified adverse events.

Follow-up Visits and Length of Follow-up 5 years

30 days, 1 year, and annually thereafter for 5 years.

Long Term F/U Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 10/03/2012 11/09/2012 Overdue/Received
one year report 04/04/2013 04/04/2013 On Time
18 month report 10/03/2013 10/04/2013 Overdue/Received
two year report 04/04/2014 04/03/2014 On Time
three year report 04/04/2015 04/03/2015 On Time
four year report 04/03/2016 04/04/2016 Overdue/Received
five year report 04/03/2017 04/03/2017 On Time
six year report 04/03/2018 03/23/2018 On Time
seven year report 04/03/2019 04/03/2019 On Time
eight year report 04/03/2020 04/03/2020 On Time
final report 01/31/2021 01/29/2021 On Time

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