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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Chronic Lead Performance


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General
Application Number P080006 / PAS002
Current Plan Approved 12/05/2013
Study Name OSB Lead-Chronic Lead Performance
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 This study utilizes the Medtronic¿s Post-Approval Network Product

Surveillance Registry (PSR) designed to conduct non-randomized, active prospective post-market Surveillance. The Registry is sponsored by Medtronic and is comprised of a global network of hospitals, clinics and clinicians from which reliable ¿real world¿ product safety and patient clinical outcome information is generated.

Study Population Description The study will consist of patients rolled over from the pre-market study and patients newly enrolled in the postapproval study all tracked within the System Longevity Study sponsor registry. These are patients indicated for chronicpacing and sensing in the left ventricle via thecardiac vein, when used in conjunction with a compatible Medtronic Cardiac Resynchronization Therapy system.
Sample Size 1778 patients, 60 sites
Data Collection The endpoints include the complication free rate will be estimated based on the chronic (> 30 days post implant) clinical adverse events including 1) failure to capture, 2) failure to sense, 3) Undersensing, 4) Threshold rise, 5) Oversensing, 6) Abnormal pacing impedance, 7) Lead insulation breach, 8) Lead conductor fracture, 9) Extracardiac stimulation, 10) Cardiac perforation, 11) Lead dislodgement, and 12) Structural Lead Failure.
Follow-up Visits and Length of Follow-up Patients will be followed every six months for 5 years
Final Study Results
Interim Safety Information There were 3 (in 3 leads) Model 4196 related observations, no Model 4196 related complication, and no deaths reported.


OSB Lead-Chronic Lead Performance Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
3 month report 07/21/2009 07/21/2009 On Time
9 month report 01/07/2010 01/06/2010 On Time
15 month report 07/07/2010 07/06/2010 On Time
21 month report 01/07/2011 12/22/2010 On Time
27 month report 07/07/2011 06/28/2011 On Time
33 month report 01/07/2012 12/22/2011 On Time
39 month report 07/07/2012 06/28/2012 On Time
45 month report 01/07/2013 01/04/2013 On Time
month report 08/09/2013 08/08/2013 Overdue/Received
51 month report 01/07/2014 01/08/2014 Overdue/Received
non-scheduled non-clinical report 04/14/2014 04/14/2014 On Time
63 month report 07/07/2014 06/26/2014 On Time
69 month report 01/07/2015 12/18/2014 On Time
75 month report 07/07/2015 07/01/2015 On Time
81 month report 01/07/2016 12/22/2015 On Time
7 year report 07/07/2016 07/07/2016 On Time
Final Report 01/07/2017    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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