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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Continued Follow-up of the IDE Study Subjects


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General
Study Status Study Pending
Application Number /
Requirement Number		 P230023 / PAS001
Date Original Protocol Accepted 01/12/2024
Date Current Protocol Accepted  
Study Name Continued Follow-up of the IDE Study Subjects
Device Name GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Assess the safety and effectiveness of the TAMBE Device in the treatment of thoracoabdominal aortic
aneurysms (TAAA) and pararenal aortic aneurysms. This is continued follow up of the premarket cohort.
Study Population Subjects with thoracoabdominal or pararenal aortic aneurysms requiring treatment of their adapted Crawford Type IV TAAA and pararenal aneurysms
Sample Size 142
Key Study Endpoints Clinical endpoints include a composite of Uncomplicated Technical Success and Procedural Safety, as well as a composite of Clinically Significant Reintervention and Lesion-related Mortality
Follow-up Visits and Length of Follow-up 5 years


Continued Follow-up of the IDE Study Subjects Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 01/11/2025    
2 year report 01/11/2026    
3 year report 01/11/2027    


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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