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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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OSB Lead-Chronic Lead Performance/Multiple MRI

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Study Status Progress Adequate
Application Number P090013 / PAS001
Date Current Protocol Accepted 02/08/2011
Study Name OSB Lead-Chronic Lead Performance/Multiple MRI
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21

OSB Lead-Chronic Lead Performance/Multiple MRI Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 08/09/2011 08/05/2011 On Time
1 year report 02/08/2012 02/02/2012 On Time
18 month report 08/08/2012 08/06/2012 On Time
2 year report 02/07/2013 02/05/2013 On Time
30 month report 08/08/2013 07/12/2013 On Time
3 year report 02/07/2014 02/05/2014 On Time
42 month report 08/07/2014 08/07/2014 On Time
4 year report 02/07/2015 02/09/2015 Overdue/Received
54 month report 08/08/2015 08/07/2015 On Time
5 year report 02/07/2016 02/08/2016 Overdue/Received
66 month report 08/07/2016 08/05/2016 On Time
6 year report 02/06/2017 02/08/2017 Overdue/Received
78 month report/final 12/29/2017 12/21/2017 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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