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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 P070027
Current Protocol Accepted 11/05/2008
Study Name OSB Lead-Vitality Trial
Study Status Completed
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 Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, one armed, non-randomized, observational, multi-site study. The purpose of this study   show the rest ...
Study Population Description Subjects will include patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered   show the rest ...
Sample Size 166 subjects from the premarket cohort, 94 new subjects from 20-30 sites
Data Collection Primary endpoint: Freedom from aneurysm-related mortality at 5 years. Death from rupture of the abdominal   show the rest ...
Followup Visits and Length of Followup Subjects are followed at 1-month, 6-months, 12-months, 24 months, 36 months, 48 months, and 60   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 260
Actual Number of Sites Enrolled 20
Patient Followup Rate 72.7%
Final Safety Findings There were three aneurysm-related deaths in the first 30 days, two more in year one,   show the rest ...
Final Effectiveness Findings Technical implant success was 98%
Study Strengths and Weaknesses Although mortality, aneurysm-related mortality, and secondary procedures were found to be higher than that in   show the rest ...
Recommendations for Labeling Changes No

OSB Lead-Vitality Trial Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 10/15/2008 10/15/2008 On Time
12 month report 05/11/2009 05/11/2009 On Time
18 month report 10/15/2009 10/14/2009 On Time
2 year report 04/08/2010 04/08/2010 On Time
3 year report 04/15/2011 04/11/2011 On Time
4 year report 04/15/2012 04/06/2012 On Time
5 year report 04/15/2013 04/05/2013 On Time
6 year report 04/15/2014 04/07/2014 On Time
7 year report 04/15/2015 04/03/2015 On Time
Final Report 04/15/2016 10/08/2015 On Time

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