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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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REVEAL New Enrollment Study


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General
Study Status Study Pending
Application Number /
Requirement Number		 P250018 / PAS001
Date Original Protocol Accepted 08/20/2026
Date Current Protocol Accepted 08/20/2026
Study Name REVEAL New Enrollment Study
Device Name RefluxStop® Device and RefluxStop® Deployment Tool
General Study Protocol Parameters


REVEAL New Enrollment Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 02/18/2027    
1 year report 08/20/2027    
18 month report 02/18/2028    
2 year report 08/19/2028    
30 month report 02/17/2029    
3 year report 08/19/2029    


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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