f Post-Approval Studies (PAS) Database
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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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Registry


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General
Study Status Terminated
Application Number /
Requirement Number		 P070027 S011/ PAS001
Date Original Protocol Accepted 02/04/2010
Date Current Protocol Accepted 07/16/2014
Study Name Registry
Device Name TALENT ABDOMINAL STENT GRAFT SYSTEM
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 Objectives Multi-center, prospective, non-randomized, single arm post-market surveillance clinical registry study.
Study Population Patients of 18 years of age and older who require secondary endovascular intervention for the prevention of AAA rupture
Sample Size 20
Key Study Endpoints 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.


Registry Reporting Schedule

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

Additional Resources

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