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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Long Term F/U Study


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General
Application Number P020018 S040/ PAS001
Current Plan Approved 12/12/2012
Study Name OSB Lead-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.



OSB Lead-Long Term F/U Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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    


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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