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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General
Application Number P070007
Most Recent Protocol Version Approved 09/03/2008
Study Name THRIVE Trial
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study will examine the post-market performance of the Talent Thoracic Stent Graft System. This   show the rest ...
Study Population Description For purposes of cohort comparability, the inclusion/exclusion criteria will match to those used for the   show the rest ...
Sample Size 195 subjects from the VALOR Test Group of the Talent Thoracic PMA Submission, and 256   show the rest ...
Data Collection The primary endpoint of this study is freedom from aneurysm-related mortality at 5 years. The   show the rest ...
Followup Visits and Length of Followup The planned follow-up is 5 years for #2002-07. Participants from the #99-03 study will be   show the rest ...


THRIVE Trial Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 12/04/2008 12/05/2008 Overdue/Received
1 year report 06/05/2009 06/03/2009 On Time
18 month report 12/04/2009 12/04/2009 On Time
2 year report 06/05/2010 06/03/2010 On Time
3 year report 06/05/2011 06/03/2011 On Time
4 year report 06/04/2012 06/04/2012 On Time
5 year report 06/04/2013 06/04/2013 On Time
6 year report 06/04/2014    

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