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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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ODE Lead-Post-Approval Study

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Study Status Progress Adequate
Application Number P020004 S123/ PAS001
Study Name ODE Lead-Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study consists of the extended follow-up data out to 5 years for subjects enrolled in the IBE 12-04 clinical study and continued access.
Study Population Description Subjects with a common iliac or aortoiliac aneurysm, who have appropriate anatomy to accommodate the device and fit the study selection criteria.
Sample Size 64 unique subjects in the IDE cohort and 18 subjects in the continued access cohort.
Data Collection Data will be provided on the following: a summary of the number of patients for whom data are available and the rates of adverse events, such as aneurysm-related mortality, aneurysm rupture, secondary endovascular procedures, conversion to open surgical repair, endoleak, aneurysm enlargement, prosthesis migration and patency, and losses of device integrity.
Follow-up Visits and Length of Follow-up 5 years


ODE Lead-Post-Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 02/28/2017 03/27/2017 Overdue/Received
two year report 02/28/2018    
three year report 02/28/2019    
four year report 02/28/2020    
five year report 02/27/2021    

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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