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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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Longitudinal Surveillance Study


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General
Study Status Completed
Application Number /
Requirement Number		 P960040 S198/ PAS001
Date Original Protocol Accepted 11/10/2010
Date Current Protocol Accepted 12/21/2012
Study Name Longitudinal Surveillance Study
Device Name TELIGEN 4-SITE MODELS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
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 Objectives The LSS of 4-SITE is a prospective, nonrandomized, multi-center registry of patients implanted with the 4-SITE Lead/Header system.
Study Population Patients implanted with the 4-SITE Lead/Header system
Sample Size 1,780 patients.(assuming an annual attrition rate of 10%, a minimum of 1,780 patients implanted with the 4-SITE lead is necessary to obtain 5-year follow-up data on approximately 1050 patients
Key Study Endpoints For the 4-SITE Lead/Header system, the primary endpoint for this registry will evaluate the proportion of patients without a chronic 4-SITE Lead/Header-related complication within five years post-implant.
Follow-up Visits and Length of Follow-up Five-years post implant
Every six months
Interim or Final Data Summary
Actual Number of Patients Enrolled 1820 subjects
Actual Number of Sites Enrolled 111 sites
Patient Follow-up Rate 5 years post-implant
Final Safety Findings The sponsor reported a complication-free rate through 60 months for the 4-SITE Lead/Header system of 98.9% with a one-sided 95% lower confidence limit of 98.5%. The lower confidence limit is higher than the performance goal of 92.5%. The sponsor also reported 17 adverse events that contributed to the primary endpoint. All lower confidence limits for all events types are within 1% of the complication free rate.
Final Effect Findings Please see above
Study Strengths & Weaknesses The sponsor has collected sufficient data to address the primary objective of the study which was to estimate the five year Endotak Reliance 4-Site defibrillation lead related chronic complication-free rate. The Agency recommends that the sponsor update the labeling to incorporate the study findings.
Recommendations for Labeling Changes FDA recommends that the sponsor update the labeling for these devices to reflect the long-term data from the Post Approval Study.


Longitudinal Surveillance Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/11/2011 05/05/2011 On Time
one year report 11/10/2011 11/02/2011 On Time
18 month report 05/10/2012 05/08/2012 On Time
two year report 11/09/2012 11/09/2012 On Time
30 month report 05/10/2013 05/06/2013 On Time
three year report 11/09/2013 11/07/2013 On Time
42 month report 05/10/2014 05/09/2014 On Time
four year report 11/21/2014 11/17/2014 On Time
54 month report 05/10/2015 05/08/2015 On Time
five year report 11/09/2015 11/05/2015 On Time
66 month report 05/09/2016 05/04/2016 On Time
six year report 05/09/2017 05/02/2017 On Time
seven year report 05/09/2018 05/01/2018 On Time
eight year report 05/09/2019 04/26/2019 On Time
final report 08/09/2020 07/30/2020 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

Additional Resources

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