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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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Study Status Progress Adequate
Application Number P140033 / PAS001
Date Current Protocol Accepted 05/22/2020
Study Name SJM Brady MRI PAS
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source Admin Database
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Primary Objective: To determine the Tendril MRI RA and Tendril MRI RV lead-related complication-free rates at 5 years.
Secondary Objective: To determine the rate of cardiac tamponade or cardiac perforation events through 5 years.
The real-world approach to identify lead-related complications will use Abbott-maintained internal databases combined with CMS-maintained Medicare claims data. Every Abbott device has a unique combination of model and serial number that is preserved across Abbott databases and can be used to link data from these databases together.
Study Population Description All patients who has an implant of an SJM system along with a Tendril MRI RA and/or RV lead, meet inclusion/exclusion criteria, and link to Medicare FFS claims will be included in the analysis of the endpoints.
Sample Size Assuming the time to first complication follows an exponential distribution and the complication free survival at 5 years is 95%, a minimal sample size of 645 Tendril MRI RA and 645 Tendril MRI RV leads provides 80% power to reject the null hypotheses of 92.5% complication-free survival years at the 5% significance level. It is estimated that 23,230 Tendril MRI RA and 22,839 Tendril MRI RV lead implants will meet inclusion /exclusion criteria for this study, which greatly exceeds the minimal required sample size.
Data Collection Primary Endpoint: Freedom from Tendril MRI RA and/or RV lead-related complications through 5-years of follow-up.
Secondary Endpoint: The secondary outcome measure is the rate of cardiac tamponade or cardiac perforation events. The objective is to characterize the rate of these events. All cardiac tamponade and cardiac perforations will be evaluated for their relationship to the Tendril MRI RA or Tendril MRI RV leads, reported and summarized.
Follow-up Visits and Length of Follow-up The study completion is 5 years after the final implant, June 30, 2018. The data retention period will be for 2 years after the submission of the final report.
Interim or Final Data Summary
Interim Safety Information The rate of freedom from lead-related complications at 3 years is 98.91% (worst case) and 99.44% (best case) for RA leads and 98.95% (worst case) and 99.38% (best case) for RV leads in the Tendril MRI RWE Study. The proportion of patients with cardiac tamponade events and cardiac perforation events was 0.6602% and 0.0611% respectively.
Actual Number of Patients Enrolled 26,205
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A
Study Strengths & Weaknesses This study is progressing as expected.

SJM Brady MRI PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 08/01/2017 08/01/2017 On Time
1 year report 01/31/2018 01/31/2018 On Time
18 month report 08/01/2018 08/01/2018 On Time
2 year report 01/31/2019 01/29/2019 On Time
3 year report 01/31/2020 01/31/2020 On Time
4 year report 01/30/2021 01/26/2021 On Time
5 year report 01/30/2022 02/09/2022 Overdue/Received
6 year report 01/30/2023    
final report 01/30/2024    

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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