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 Premarket Cohort

General
Study Status	Study Pending
Application Number / Requirement Number	P240003 / PAS001
Date Original Protocol Accepted	08/28/2024
Date Current Protocol Accepted
Study Name	Continued Follow-up of the Premarket Cohort
Device Name	Minima Stent System
Clinical Trial Number(s)	NCT05086016
General Study Protocol Parameters

Continued Follow-up of the Premarket Cohort Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	02/26/2025
1 year report	08/28/2025
18 month report	02/26/2026
2 year report	08/28/2026
3 year report	08/28/2027

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