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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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Post-Approval Study Registry

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Study Status Completed
Application Number P080006 S073/ PAS001
Date Current Protocol Accepted 12/10/2014
Study Name Post-Approval Study Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Interim or Final Data Summary
Actual Number of Patients Enrolled see p080006/S068 for all results

Post-Approval Study Registry Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report-bundled with S68 01/30/2015 01/26/2015 On Time
one year report-bundled 08/01/2015 07/28/2015 On Time
18 month report 01/30/2016 12/17/2015 On Time
two year report 07/31/2016 07/29/2016 On Time
three year report 07/31/2017 07/24/2017 On Time
four year report 07/31/2018 07/27/2018 On Time
five year report 07/31/2019 07/29/2019 On Time
six year report 07/31/2020 07/29/2020 On Time
final Report 07/31/2021 07/30/2021 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