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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-Registry

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Application Number P070027 S011/ PAS001
Current Plan Approved 07/16/2014
Study Name OSB Lead-Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Multi-center, prospective, non-randomized, single arm post-market surveillance clinical registry study.

Study Population Description Patients of 18 years of age and older who require secondary endovascular intervention for the prevention of AAA rupture

Sample Size 20
Data Collection Endovascular treatment success, failure mode, adverse events, AAA-related mortality, all cause mortality, conversions to open surgery, secondary procedures, aneurysm growth, stent graft migration, integrity, and patency, endoleaks.
Follow-up Visits and Length of Follow-up No specified - to be determined by standard of care. 5 years.

OSB Lead-Registry Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 08/05/2010 08/02/2010 On Time
1 year report 02/04/2011 02/03/2011 On Time
18 month report 08/05/2011 08/03/2011 On Time
2 year report 02/04/2012 02/02/2012 On Time
3 year report 02/03/2013 01/31/2013 On Time
4 year report 02/03/2014 01/31/2014 On Time
5 year report 02/03/2015 01/30/2015 On Time
6 year report 02/03/2016 02/01/2016 On Time

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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