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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 Terminated
Application Number /
Requirement Number		 P830060 S062/ PAS001
Date Original Protocol Accepted 01/14/2011
Date Current Protocol Accepted 01/14/2011
Study Name Longitudinal Surveillance Study
Device Name LEAD TUNNELER MODEL 6888
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


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


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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