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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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Longitudinal Surveillance Study

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Study Status Progress Adequate
Application Number P010012 S212/ PAS001
Date Current Protocol Accepted 01/14/2011
Study Name Longitudinal Surveillance Study
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 Design Description The LSS of 4-SITE is a prospective, nonrandomized, multi-center registry of patients implanted with the 4-SITE Lead/Header system.
Study Population Description 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)
Data Collection 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 Schedule

Report Schedule
Date Due
FDA Receipt
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    

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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