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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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OSB Lead-Training Program

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Study Status Completed
Application Number P020018 S040/ PAS002
Date Current Protocol Accepted 04/02/2014
Study Name OSB Lead-Training Program
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Multicenter single-arm registry study
Study Population Description Patients undergoing treatment for AAA with the Zenith fenestrated AAA endovascular graft who completed training program; no control group
Sample Size 82 subjects; no controls
Data Collection Technical success of implant
Follow-up Visits and Length of Follow-up None


Interim or Final Data Summary
Actual Number of Patients Enrolled 82
Actual Number of Sites Enrolled 47
Patient Follow-up Rate 100%
Final Safety Findings No safety endpoints in this study
Final Effect Findings Technical success rate if implantation = 91.5%
Study Strengths & Weaknesses There was 100% follow쳌]up of study subjects, and endpoint was fully assessed in all subjects. The primary endpoint was met by a wide margin. There were no significant weaknesses in this study.
Recommendations for Labeling Changes No labeling change is recommended because there is no new information that is thought to be of sufficient value to justify a labeling change.

OSB Lead-Training Program Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 10/03/2012 11/09/2012 Overdue/Received
one year report 04/04/2013 04/04/2013 On Time
18 month report 10/03/2013 10/04/2013 Overdue/Received
two year report 04/04/2014 04/02/2014 On Time
Final Report 07/03/2014 07/03/2014 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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