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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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Shield Post-Approval Study


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General
Study Status Protocol Pending
Application Number /
Requirement Number		 P230009 / PAS001
Study Name Shield Post-Approval Study
Device Name Shield
Clinical Trial Number(s) NCT04136002 
General Study Protocol Parameters


Shield Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 01/24/2025    
1 year report 07/26/2025    
18 month report 01/24/2026    
2 year report 07/26/2026    
3 year report 07/26/2027    
4 year report 07/25/2028    
5 year report 07/25/2029    


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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