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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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New Enrollment

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Study Status Revised/Replaced Study
Application Number P090018 / PAS002
Date Current Protocol Accepted 03/18/2016
Study Name New Enrollment
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 A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21

New Enrollment Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 09/15/2010 09/16/2010 Overdue/Received
one year report 03/17/2011 03/16/2011 On Time
18 month report 09/15/2011 09/15/2011 On Time
2 year report 03/16/2012 03/14/2012 On Time
3 year report 03/16/2013 05/08/2013 Overdue/Received
4 year report 03/16/2014 03/14/2014 On Time
non-scheduled report 05/05/2014 05/05/2014 On Time
5 year report 04/14/2015 04/14/2015 On Time

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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