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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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The Patient Exposure Study


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General
Study Status Study Pending
Application Number P200029 / PAS001
Date Current Protocol Accepted  
Study Name The Patient Exposure Study
General Study Protocol Parameters
Study Design Other Study Design
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description To calculate the radiation-absorbed dose of Technetium-99m macroaggregated albumin (Tc-99m MAA), as described in the approved TheraSphere Instructions For Use (IFU), to the whole body and to potential irradiated non-liver critical organs.
Study Population Description Patients who are being evaluated for TheraSphere administration according to the approved TheraSphere IFU.
Sample Size 5
Data Collection Mean absorbed dose (Gy) and activity (Bq) will be summarized for the whole body and for critical non-liver organs (including whole body effective dose).
Follow-up Visits and Length of Follow-up 24 hours; 3 times within 24 hours


The Patient Exposure Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/15/2021 09/14/2021 On Time
1 year report 03/17/2022    
18 month report 09/15/2022    
2 year report 03/17/2023    
3 year report 03/16/2024    
4 year report 03/16/2025    


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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