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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 P060039
Current Protocol Accepted 11/19/2013
Study Name OSB Lead-Chronic Performance Study
Study Status Progress Adequate
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 study is a non-randomized, multi-site, clinical study of implanted commercially available Model 4195 leads.   show the rest ...
Study Population Description The Attain StarFix Model 4195 steroid eluting, transvenous lead with deployable lobe fixation is intended   show the rest ...
Sample Size 1,016 patients will be enrolled to achieve an evaluable sample size of 600 for 5-year   show the rest ...
Data Collection The primary objective of the study is to demonstrate that the Model 4195 lead-related complication-free   show the rest ...
Followup Visits and Length of Followup The follow-up schedule for this study is based on utilizing routine, scheduled office/clinic visits and   show the rest ...

OSB Lead-Chronic Performance Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 01/13/2009 06/04/2009 Overdue/Received
1 year report 02/02/2010 11/25/2009 On Time
18-month report 05/28/2010 05/28/2010 On Time
2 year report 11/26/2010 11/26/2010 On Time
30 month report 05/29/2011 05/27/2011 On Time
3 year report 11/26/2011 11/18/2011 On Time
42 month report 05/29/2012 05/23/2012 On Time
4 year report 11/29/2012 11/20/2012 On Time
54 month report 05/29/2013 05/23/2013 On Time
5 year report 11/29/2013 11/27/2013 On Time
66 month report 05/27/2014 05/27/2014 On Time
60 month report 05/29/2014 04/30/2014 On Time
6 year report 11/29/2014 11/21/2014 On Time
78 month report 05/29/2015 05/27/2015 On Time
7 year report 11/29/2015 11/23/2015 On Time
90 month report 05/29/2016 05/27/2016 On Time
8 year report 11/29/2016    
102 month report 05/29/2017    
Final Report 08/29/2017    

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