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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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Clinical Study

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Study Status Progress Adequate
Application Number P860057 S042/ PAS001
Date Current Protocol Accepted 11/03/2009
Study Name Clinical Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21

Clinical Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 08/05/2010 08/04/2010 On Time
1 year report 11/05/2010 11/02/2010 On Time
18 month report 05/07/2011 05/09/2011 Overdue/Received
2 year report 11/05/2011 11/04/2011 On Time
3 year report 08/04/2012 08/01/2012 On Time
4 year report 05/06/2013 06/25/2013 Overdue/Received
5 year report 05/06/2014 05/05/2014 On Time
6 year report 05/06/2015 04/30/2015 On Time
7 year report 05/05/2016 05/02/2016 On Time
8 year report 05/05/2017 05/01/2017 On Time
Final Report 11/30/2018 11/29/2018 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

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