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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 P950022 S042
Current Protocol Accepted 05/07/2009
Study Name OSB Lead-SJ4 PAS
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 study is designed to characterize the chronic performance of the SJM SJ4 connector and   show the rest ...
Study Population Description Study Population: Patients with an approved indication, as per profession society guidelines, for implantation of   show the rest ...
Sample Size 1700 patients, 60 sites
Data Collection Complication free survival rate at 5 years for complications related to the right ventricular lead   show the rest ...
Followup Visits and Length of Followup Patients will be followed every six months for 5 years
Final Study Results
Actual Number of Patients Enrolled 1701
Actual Number of Sites Enrolled 58
Patient Followup Rate 78.01%
Final Safety Findings The 95% Lower Confidence Bound (LCB) for the freedom from complications using the Kaplan-Meier method   show the rest ...
Final Effectiveness Findings The mean RV lead capture threshold is less than 1 V for all follow-up visits.
Study Strengths and Weaknesses 1) Large sample size of 1701 subjects

2) Long-term follow-up for 5 years)


2) Study deviation   show the rest ...
Recommendations for Labeling Changes no

OSB Lead-SJ4 PAS Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 07/14/2009 09/01/2009 Overdue/Received
1 year report 01/22/2010 01/20/2010 On Time
18 month report 07/14/2010 07/14/2010 On Time
2 year report 01/13/2011 01/13/2011 On Time
30 month report 07/14/2011 07/13/2011 On Time
3 year report 01/13/2012 01/13/2012 On Time
request to change cutoff report dates 02/15/2012 02/15/2012 On Time
42 month report 07/31/2012 10/03/2012 On Time
4 year report 01/31/2013 01/30/2013 On Time
5 year report 01/31/2014 01/29/2014 On Time
6 year report 01/31/2015 01/29/2015 On Time
Final Report 01/29/2016 01/05/2016 On Time

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