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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.


Contact Information

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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Application Number P020018 S040
Current Protocol Accepted 12/12/2012
Study Name OSB Lead-Long Term F/U Study
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective & Retrospective 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 A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Observational, single-arm, multi-center, prospective cohort study
Study Population Description Subjects from the pivotal trial plus at least 20 new subjects
Sample Size 88
Data Collection Primary endpoint: 5-year aneurysm-related mortality rate;

Secondary endpoints: Aneurysm rupture, conversion to open surgery, device integrity,   show the rest ...
Followup Visits and Length of Followup 5 years

30 days, 1 year, and annually thereafter for 5 years.

OSB Lead-Long Term F/U Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 10/03/2012 11/09/2012 Overdue/Received
one year report 04/04/2013 04/04/2013 On Time
18 month report 10/03/2013 10/04/2013 Overdue/Received
two year report 04/04/2014 04/03/2014 On Time
three year report 04/04/2015 04/03/2015 On Time
four year report 04/03/2016 04/04/2016 Overdue/Received
five year report 04/03/2017    

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