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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 P110032
Current Protocol Accepted 11/01/2013
Study Name OSB Lead-Aorfix Post Approval Study
Study Status Terminated
Study Progress Reason Other reason
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source External Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a prospective observational study with a historical control, including both prospective follow-up   show the rest ...
Study Population Description The study will include 234 prospectively enrolled subjects treated in accordance with the IFU for   show the rest ...
Sample Size 455 subjects, including 234 newly enrolled subjects plus 221 from the premarket cohort.

A minimum of   show the rest ...
Data Collection  Aneurysm-related mortality at 5 years (primary endpoint)

 Major adverse events at 30 days, and   show the rest ...
Followup Visits and Length of Followup 5 years

30 day post-implant, one year, and annually thereafter

OSB Lead-Aorfix Post Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 08/15/2013 11/27/2013 Overdue/Received
one year report 02/14/2014 03/14/2014 Overdue/Received

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