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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 P040043
Most Recent Protocol Version Approved 08/31/2005
Study Name Cohort Study
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 Concurrent Control
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, non-randomized, prospective observational study, designed to compare device users with historical   show the rest ...
Study Population Description The study population will include subjects enrolled into the TAG pre-market studies (TAG 97-01, TAG   show the rest ...
Sample Size 450 TAG subjects and 94 surgical control subjects, 35 sites
Data Collection The primary objective of this study is to evaluate the long-term performance of the TAG   show the rest ...
Followup Visits and Length of Followup Follow-up visits will be accomplished at discharge, 30 days post-implant, and annually thereafter, for a   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 449 overall (150 training study + 299 IDE participants)
Actual Number of Sites Enrolled 25 (in training study)
Patient Followup Rate 78%
Final Safety Findings Reintervention:

Twenty쳌]nine (29) (6% of total) required 31 secondary interventions with additional endoprosthesis implants. Three (3)   show the rest ...
Final Effectiveness Findings 5쳌]year aneurysm쳌]related mortality rate = 94.7%

1 ruptured aneurysm (0.2%)

1 case of device migration (0.2%)

  show the rest ...
Study Strengths and Weaknesses Strengths: Prospective cohort study; success criteria for primary endpoint met by large margin;

concurrent control group.

Weakness:   show the rest ...
Recommendations for Labeling Changes Yes: Recommend update to reflect results of PAS


Cohort Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 09/21/2005 10/07/2005 Overdue/Received
1 year report 03/23/2006 03/31/2006 Overdue/Received
18 month reports 09/21/2006 10/10/2006 Overdue/Received
2 year annual report w/pas data 03/23/2007 04/19/2007 Overdue
2 year report 03/23/2007 04/13/2007 Overdue/Received
42 month year report 09/22/2007 10/02/2007 Overdue/Received
3 year report 03/22/2008 03/31/2008 Overdue/Received
4 year report 03/22/2009 03/25/2009 Overdue/Received
5 year report 03/22/2010 03/25/2010 Overdue/Received
6 year report 03/22/2011 03/23/2011 Overdue/Received
7 year report 03/21/2012 03/21/2012 On Time
8 year report 03/22/2013 03/22/2013 On Time
amended final report 02/21/2014 02/21/2014 On Time
9 year report-FINAL REPORT 03/22/2014 01/24/2014 On Time

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