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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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General
Study Status Completed
Application Number P080006 S002/ PAS001
Date Current Protocol Accepted 04/01/2011
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
Interim or Final Data Summary
Actual Number of Patients Enrolled 1140
Actual Number of Sites Enrolled 119
Patient Follow-up Rate 85.2%
Final Safety Findings The primary safety endpoint is lead complication free rate >92.5% at 5 years. The most common event is lead dislodgement, followed by infection and stimulation issue. The complication free rate at 60 months is 96.33%. Dislodgements (2.36%) are known to be common for LV leads. Most of the returned leads were found to be ok with no anomalies found. None of the deaths were related to the lead.
Final Effect Findings Electrical performance appears to be within adequate ranges.



Study Strengths & Weaknesses Enrollment exceeded expectations and follow up rate was adequate. A common deviation was incomplete data collection during follow up visits, which may impact overall information available for assessments.
Recommendations for Labeling Changes Yes


Chronic Lead Performance Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/30/2011 09/28/2011 On Time
one year report 03/31/2012 03/26/2012 On Time
18 month report 09/29/2012 09/27/2012 On Time
two year report 03/31/2013 03/28/2013 On Time
30 month report 09/29/2013 09/27/2013 On Time
three year report 03/31/2014 03/21/2014 On Time
42 month report 09/29/2014 09/24/2014 On Time
four year report 03/31/2015 03/16/2015 On Time
54 month report 09/29/2015 09/22/2015 On Time
five year report 03/30/2016 03/25/2016 On Time
66 month report 09/30/2016 09/28/2016 On Time
six year report 03/30/2017 03/27/2017 On Time
78 month report 09/30/2017 09/27/2017 On Time
seven year report 03/30/2018 03/27/2018 On Time
90 month report 09/30/2018 09/26/2018 On Time
final report 03/30/2019 03/28/2019 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

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