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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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Post Approval Study

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Study Status Progress Inadequate
Application Number P040040 / PAS002
Date Current Protocol Accepted 03/18/2016
Study Name Post Approval Study
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21, All Pediatric Patients: 0-21 yrs

Post Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 10/01/2008 09/08/2008 On Time
2 year report 09/06/2009 09/03/2009 Overdue
3 year report 09/06/2010 09/07/2010 Overdue/Received
4 year report 09/06/2011 09/06/2011 On Time
5 year report 09/05/2012 09/05/2012 On Time
6 year report 09/05/2013 08/30/2013 On Time
7 year report 09/05/2014 09/05/2014 On Time
8 year report 09/05/2015 09/08/2015 Overdue/Received
9 year report 09/04/2016 09/02/2016 On Time
10 year report 09/07/2017 09/07/2017 On Time
11 year report 09/07/2018 09/07/2018 On Time
12 year report 09/07/2019    

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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