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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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Study Status Completed
Application Number P950022 S042/ PAS001
Date Current Protocol Accepted 05/07/2009
Study Name OSB Lead-SJ4 PAS
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
Detailed Study Protocol Parameters
Study Design Description This study is designed to characterize the chronic performance of the SJM SJ4 connector and RV high voltage SJ4 leads. The primary study question is to evaluate whether the SJ4 system complication-free rate is greater than 92.5% at 5 years
Study Population Description Study Population: Patients with an approved indication, as per profession society guidelines, for implantation of an implantable cardioverter defibrillator or cardiac resynchronization therapy-defi system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s). Indication: The device is indicated for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
Sample Size 1700 patients, 60 sites
Data Collection Complication free survival rate at 5 years for complications related to the right ventricular lead or SJ4 connector is greater than 92.5%. The following complications will be included in this analysis: Cardiac perforation, Lead dislodgement that occurred greater than 30 days after implant, Lead insulation damage, Lead fracture, Lead/Port damage, Abnormal right ventricular lead performance (abnormal lead defibrillation impedance, abnormal lead pacing impedance, elevated pacing thresholds, loss of capture, loss of defibrillation output, loss of sensing, oversensing, undersensing), Other unexpected complications that are considered related to the RV lead or SJ4 connector
Follow-up Visits and Length of Follow-up Patients will be followed every six months for 5 years
Interim or Final Data Summary
Interim Safety Information 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)


2) Study deviation rate of 14.39% per visit

Recommendations for Labeling Changes no

OSB Lead-SJ4 PAS Schedule

Report Schedule
Date Due
FDA Receipt
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

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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