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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 P110038
Current Protocol Accepted 03/06/2015
Study Name OSB Lead-Relay Thoracic Stent-Graft w Plus Del Sys
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 is a multi-center observational prospective cohort study.
Study Population Description 120 pivotal study subjects +

13 Continued Access subjects +

100 subjects treated with the device post-approval   show the rest ...
Sample Size 233
Data Collection The primary endpoint: Freedom from aneurysm-related mortality at 5 years.

Secondary Endpoints:

Training effectiveness; major device   show the rest ...
Followup Visits and Length of Followup 5 years

1 month, 1 year, and annually thereafter

OSB Lead-Relay Thoracic Stent-Graft w Plus Del Sys Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 03/22/2013 05/06/2013 Overdue/Received
one year report 09/21/2013 09/19/2013 On Time
18 month report 04/30/2014 04/30/2014 On Time
two year report 09/21/2014 09/09/2014 On Time
three year report 09/21/2015 07/28/2015 On Time
42 month report 03/21/2016 03/21/2016 On Time
four year report 09/20/2016    
five year report 09/20/2017    

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