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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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Study Status Progress Adequate
Application Number P100021 / PAS001
Date Current Protocol Accepted 01/24/2014
Study Name OSB Lead-ENGAGE
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21

OSB Lead-ENGAGE Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 06/16/2011 06/16/2011 On Time
one year report 12/16/2011 12/14/2011 On Time
18 month report 06/15/2012 06/13/2012 On Time
two year report 12/15/2012 12/11/2012 On Time
three year report 12/15/2013 12/05/2013 On Time
four year report 12/15/2014 12/08/2014 On Time
five year report 12/15/2015 11/27/2015 On Time
six year report 12/15/2016 12/05/2016 On Time
final report 12/15/2017 12/14/2017 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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