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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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Chronic Lead Performance

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Study Status Progress Adequate
Application Number P010031 S176/ PAS001
Date Current Protocol Accepted 11/22/2013
Study Name 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 The Medtronic Post-Approval Network (PAN) is 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. Primary objective: To demonstrate that the complication- free probability is greater than 92.5% at five years post- implant for the high voltage DF4 connector.
Study Population Description This study will consist of 1,778 patients implanted with a DF-

4 connector system, enrolled at one of approximately 150 centers globally. Subjects that meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

Inclusion Criteria

¿ Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements

¿ Subject is implanted with a DF-4 connector system.

¿ Subject within 30 days of implant

Exclusion Criteria

¿ Subject who is, or will be inaccessible for follow-up at a site

¿ Subject with exclusion criteria required by local law

(Europe, Central Asia [ECA] only)

¿ Complete implant and follow-up data, including any product-related events at implant through the time of enrollment are unavailable

Sample Size Accounting for attrition, a minimum enrollment of 1778 DF4 connectors are estimated to be required in order to achieve the desired sample size for the primary objective analysis at five years.
Data Collection A list of lead-related events eligible to be included in the primary objective: Failure to capture, Failure to sense/ Undersensing, Oversensing, Threshold rise, Abnormal pacing impedance, Abnormal defibrillation impedance (RV and/or SVC coil), Lead insulation breach, Lead conductor fracture, Extra cardiac stimulation, Lead dislodgement, Cardiac perforation, Structural Lead Failure.
Follow-up Visits and Length of Follow-up Subjects will be followed for a minimum of 5 years from their implant date. Therefore, the expected duration of the DF4 PAS is approximately 7 years.

Frequency of f/u is every 6 months

Chronic Lead Performance Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 07/09/2012 07/05/2012 On Time
one year report 01/08/2013 01/07/2013 On Time
18 month report 07/09/2013 07/08/2013 On Time
two year report 01/08/2014 01/09/2014 Overdue/Received
30 month report 07/09/2014 07/08/2014 On Time
three year report 01/08/2015 01/07/2015 On Time
42 month report 07/09/2015 07/08/2015 On Time
four year report 01/08/2016 01/07/2016 On Time
54 month report 07/08/2016 07/07/2016 On Time
five year report 01/07/2017 01/06/2017 On Time
66 month report 07/09/2017 07/07/2017 On Time
6 year report 01/09/2018 12/20/2017 On Time
final report 07/09/2018 07/05/2018 On Time

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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