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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 P050006
Current Protocol Accepted 12/13/2006
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is prospective cohort study. The study population consists of two different cohorts: 1)   show the rest ...
Study Population Description The GORE HELEX Septal Occluder is a permanently implanted prosthesis indicated for the percutaneous, transcatheter   show the rest ...
Sample Size 200 patients, 19 sites
Data Collection Composite Clinical Success is evaluated at 12 months and is defined as a subject with   show the rest ...
Followup Visits and Length of Followup The safety endpoints defined above will be evaluated annually through 5 years post procedure. The   show the rest ...
Final Study Results
Actual Number of Patients Enrolled Continued Access Study: 50

PAS: 215

Actual Number of Sites Enrolled Continued Access Study: 13

Post-approval Study (PAS): 21 sites

Patient Followup Rate Continued Access Study: 70% PAS: 76%
Final Safety Findings Continued Access Study:

Major adverse events were reported in 6.0% (3/50) of subjects. These included 2   show the rest ...
Final Effectiveness Findings Continued Access Study:

Clinically successful defect closure was observed in 91.5% (43/47), 84.2% (16/19), and 87.5%   show the rest ...
Study Strengths and Weaknesses Continued Access Study: The 50 subjects in this study provided safety and efficacy data in   show the rest ...
Recommendations for Labeling Changes It is not recommended because W.L. Gore & Associates, Inc. ceased the production of the   show the rest ...


Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 02/12/2007 02/12/2007 On Time
1 year report 08/11/2007 07/19/2007 On Time
2 year report 08/11/2008 08/11/2008 On Time
3 year report 08/10/2009 08/04/2009 On Time
4 year report 08/10/2010 07/16/2010 On Time
5 year report 08/10/2011 07/16/2010 On Time
6 year report 08/09/2012 07/18/2011 On Time
7 year report 08/10/2012 08/01/2012 On Time
8 year report 08/10/2013 08/05/2013 On Time
9 year report 08/11/2014 08/08/2014 On Time
Final report 03/11/2015 03/09/2015 On Time

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