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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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ODE Lead-Siello Pacing Lead Study


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General
Study Status Progress Adequate
Application Number P950037 S156/ PAS001
Study Name ODE Lead-Siello Pacing Lead Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Other Data Source
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description a prospective, multi-center, nonrandomized clinical study to characterize chronic lead performance following device implant, as well as a robust process to retrospectively collect implant data for each study subject;
Sample Size a sample size of 1253 leads that were used for premarket endpoint analyses;
Data Collection a primary safety endpoint that results in a 95% one-sided lower pointwise confidence limit of the complication-free rate via log-log methodology for all eligible leads will be greater than performance goal of 92.5%;
Follow-up Visits and Length of Follow-up a post-approval study duration of at least 5 years;


ODE Lead-Siello Pacing Lead Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/07/2016 12/07/2016 On Time
18 month report 12/07/2017    
yearly report 12/07/2018    


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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