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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 P040036
Current Protocol Accepted 08/11/2006
Study Name NaviStar Study
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
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 prospective, observational, multi-site, non-randomiz+Z40ed, single arm study (please expand). This study is   show the rest ...
Study Population Description All patients who are considered for a radio frequency ablation procedure for drug refractory sustained,   show the rest ...
Sample Size 249 total subjects and 224 evaluable subjects, 18 sites
Data Collection Endpoints include: 1) One-year all cause mortality, 2) Cardiovascular-specific adverse event at one week, 3)   show the rest ...
Followup Visits and Length of Followup Follow-up period will be three years, with follow-up visits every 6 months.

NaviStar Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
3 month report 11/10/2006 12/01/2006 Overdue/Received
6 month report 02/09/2007 03/01/2007 Overdue/Received
9 month report 05/11/2007 05/03/2007 On Time
1 year report 08/11/2007 08/06/2007 On Time
15 month report 11/10/2007 11/09/2007 On Time
18 month report 02/09/2008 02/11/2008 Overdue/Received
21 month report 05/10/2008 05/09/2008 On Time
2 year report 08/10/2008 08/08/2008 On Time
27 month report 11/09/2008 11/07/2008 On Time
30 month report 02/08/2009 02/06/2009 On Time
33 month report 05/10/2009 05/08/2009 On Time
3 year report 08/10/2009 08/07/2009 On Time
39 month report 11/10/2009 11/09/2009 On Time
42 month report 02/08/2010 02/05/2010 On Time
4 year report 08/10/2010 08/10/2010 On Time
5 year report 08/10/2011 08/08/2011 On Time
6 year report 08/09/2012 08/03/2012 On Time
final report 11/22/2013 11/22/2013 On Time

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