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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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Longterm PAS

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Study Status Progress Adequate
Application Number P070016 / PAS001
Date Current Protocol Accepted 12/06/2011
Study Name Longterm PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21

Longterm PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 11/21/2008 11/20/2008 On Time
1 year report 05/21/2009 05/20/2009 On Time
18 month report 11/21/2009 11/20/2009 On Time
2 year report 05/21/2010 05/14/2010 On Time
3 year report 05/21/2011 05/19/2011 On Time
4 year report 05/21/2012 05/21/2012 On Time
5 year report 05/21/2013 05/20/2013 On Time
6 year report 05/21/2014 05/21/2014 On Time
7 year report 05/21/2015 05/19/2015 On Time
8 year report 05/21/2016 05/20/2016 On Time
9 year report 05/21/2017 05/16/2017 On Time
10 year report 05/21/2018 05/17/2018 On Time
11 year report 05/21/2019    
final report 03/15/2021    

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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