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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-Relay Thoracic Stent-Graft w Plus Del Sys


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General
Application Number P110038 / PAS001
Current Plan Approved 03/06/2015
Study Name OSB Lead-Relay Thoracic Stent-Graft w Plus Del Sys
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
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 is a multi-center observational prospective cohort study.
Study Population Description 120 pivotal study subjects +

13 Continued Access subjects +

100 subjects treated with the device post-approval at centers that did not participate in the premarket study.

Sample Size 233
Data Collection The primary endpoint: Freedom from aneurysm-related mortality at 5 years.



Secondary Endpoints:

Training effectiveness; major device related adverse events

Follow-up Visits and Length of Follow-up 5 years

1 month, 1 year, and annually thereafter



OSB Lead-Relay Thoracic Stent-Graft w Plus Del Sys Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/22/2013 05/06/2013 Overdue/Received
one year report 09/21/2013 09/19/2013 On Time
18 month report 04/30/2014 04/30/2014 On Time
two year report 09/21/2014 09/09/2014 On Time
three year report 09/21/2015 07/28/2015 On Time
42 month report 03/21/2016 03/21/2016 On Time
four year report 09/20/2016    
five year report 09/20/2017    


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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