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.

Learn more...

4WEB Medical Talar Replacement Device PAS

General
Study Status	Protocol Pending
Application Number / Requirement Number	H240001 / PAS001
Study Name	4WEB Medical Talar Replacement Device PAS
Device Name	4WEB Medical Talar Replacement Device
General Study Protocol Parameters
Study Population	Adult: >21

4WEB Medical Talar Replacement Device PAS Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	06/27/2025
1 year report	12/27/2025
18 month report	06/27/2026
2 year report	12/27/2026

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

---

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