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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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Long Term Study

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Study Status Progress Adequate
Application Number P050016 / PAS001
Date Current Protocol Accepted 11/04/2008
Study Name Long Term Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21

Long Term Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report (Long Term) 01/01/2008 01/02/2008 Overdue/Received
1 year report (Long Term) 07/02/2008 06/27/2008 On Time
18 month report (Long Term) 12/31/2008 12/31/2008 On Time
2 year report (Long Term) 07/02/2009 07/02/2009 On Time
3 year report (Long Term) 07/02/2010 07/01/2010 On Time
4 year report (Long Term) 07/02/2011 07/15/2011 Overdue/Received
5 year report (Long Term) 07/01/2012 07/20/2012 On Time
6 year report (Long Term) 07/01/2013 07/26/2013 Overdue/Received
7 year report (Long Term) 08/15/2014 08/07/2014 On Time
8 year report (Long Term) 08/17/2015 08/17/2015 On Time
Final Report 09/01/2017 09/05/2017 Overdue/Received

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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