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 IDE Study Subjects

General
Study Status	Ongoing
Application Number / Requirement Number	P250055 / PAS001
Date Original Protocol Accepted	06/26/2026
Date Current Protocol Accepted	06/26/2026
Study Name	Continued Follow-up of IDE Study Subjects
Device Name	AMDS Hybrid Prosthesis
Clinical Trial Number(s)	NCT03035643 NCT03397251 NCT05174767
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Adult: At least 22 yrs

Continued Follow-up of IDE Study Subjects Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	06/26/2027
2 year report	06/25/2028
3 year report	06/25/2029
4 year report	06/25/2030

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