f Post-Approval Studies (PAS) Database
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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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URINATE PAS (PR1276)


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General
Study Status Delayed
Application Number /
Requirement Number		 P210020 / PAS002
Date Original Protocol Accepted 02/03/2022
Date Current Protocol Accepted 06/10/2022
Study Name URINATE PAS (PR1276)
Device Name Optilume Urethral Drug Coated Balloon
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Interim or Final Data Summary
Actual Number of Patients Enrolled 87
Actual Number of Sites Enrolled 11


URINATE PAS (PR1276) Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 06/03/2022 06/03/2022 On Time
1 year report 12/03/2022 11/29/2022 On Time
18 month report 06/03/2023 06/01/2023 On Time
2 year report 12/03/2023 11/29/2023 On Time
3 year report 12/02/2024    


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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