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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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Patient Specific Talus Spacer PAS


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General
Study Status Other
Application Number H200001 / PAS001
Date Current Protocol Accepted  
Study Name Patient Specific Talus Spacer PAS
General Study Protocol Parameters


Patient Specific Talus Spacer PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/18/2021 08/16/2021 On Time
1 year report 02/17/2022    
18 month report 08/18/2022    
2 year report 02/17/2023    
3 year report 02/17/2024    
4 year report 02/16/2025    


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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