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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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Relay Thoracic Stent-Graft w Plus Del Sys


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General
Study Status Progress Adequate
Application Number P110038 / PAS001
Date Current Protocol Accepted 02/06/2018
Study Name 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 Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21


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 09/21/2016 Overdue/Received
five year report 09/20/2017 10/02/2017 Overdue/Received
six year report 09/20/2018 09/21/2018 Overdue/Received
seven year report 09/20/2019    
eight year report 09/21/2020    
nine year report 09/20/2021    
ten year report 09/20/2022    
final report 12/22/2023    


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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