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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Urgency Frequency (UF 1635)

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Study Status Redesigned/Replaced Study
Application Number /
Requirement Number
P970004 S022/ PAS001
Date Original Protocol Accepted 09/24/2002
Date Current Protocol Accepted 10/23/2007
Study Name Urgency Frequency (UF 1635)
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21

Urgency Frequency (UF 1635) Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 04/18/2008 04/23/2008 Overdue/Received
1 year report 10/20/2008 10/23/2008 Overdue/Received
18 month report 04/23/2009 04/23/2009 On Time
2 year report 10/23/2009 10/23/2009 On Time

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