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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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Long Term PAS

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Study Status Terminated
Application Number H080002 / PAS001
Date Current Protocol Accepted 09/24/2013
Study Name Long Term PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21

Long Term PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 07/26/2010 07/19/2010 On Time
1 year report 01/25/2011 01/26/2011 Overdue/Received
18 month report 07/26/2011 07/26/2011 On Time
2 year report 01/25/2012 01/25/2012 On Time
30 month report 07/25/2012 07/25/2012 On Time
request to move report dates 08/10/2012 08/10/2012 On Time
3 year report 07/26/2013 07/26/2013 On Time
4 year report 07/26/2014 07/24/2014 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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