Post-Approval Studies (PAS) Database

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

General
Study Status	Study Pending
Application Number / Requirement Number	P250050 / PAS001
Date Original Protocol Accepted	09/25/2026
Date Current Protocol Accepted	09/25/2026
Study Name	Continued Follow-up of the IDE Study Subjects
Device Name	Liverty™ TIPS Stent Graft
Clinical Trial Number(s)	NCT05711316
General Study Protocol Parameters

Continued Follow-up of the IDE Study Subjects Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	03/26/2027
1 year report	09/25/2027
2 year report	09/24/2028
3 year report	09/24/2029
4 year report	09/24/2030

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background