f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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SJ4 PAS


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General
Study Status Completed
Application Number /
Requirement Number		 P950022 S042/ PAS001
Date Original Protocol Accepted 01/13/2009
Date Current Protocol Accepted 05/07/2009
Study Name SJ4 PAS
Device Name RIATA ST OPTIM AND RIATA STS OPTIM
General Study Protocol Parameters
Study Design Prospective Cohort Study
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
Interim or Final Data Summary
Interim Results There were 34 device-related complications in 22 patients in the post-approval study. Of the 34 complications, 13 have been classified as right ventricular lead or SJ4 connector related complications.
Actual Number of Patients Enrolled 1701
Actual Number of Sites Enrolled 58
Patient Follow-up Rate 78.01%
Final Safety Findings The 95% Lower Confidence Bound (LCB) for the freedom from complications using the Kaplan-Meier method at 5 years was 95.5%.
Final Effect Findings The mean RV lead capture threshold is less than 1 V for all follow-up visits.
Study Strengths & Weaknesses 1) Large sample size of 1701 subjects
2) Long-term follow-up for 5 years)
Weakness:
2) Study deviation rate of 14.39% per visit
Recommendations for Labeling Changes no


SJ4 PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's 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


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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