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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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New Enrollment Study


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General
Study Status Progress Adequate
Application Number P130016 / PAS002
Date Current Protocol Accepted 09/22/2017
Study Name New Enrollment Study
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21


New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/18/2014 09/19/2014 Overdue/Received
one year report 03/20/2015 03/20/2015 On Time
18 month report 09/18/2015 09/17/2015 On Time
two year report 03/19/2016 03/17/2016 On Time
three year report 03/19/2017 03/17/2017 On Time
four year report 03/19/2018 03/14/2018 On Time
five year report 03/19/2019    
six year report 03/18/2020    
seven year report 03/18/2021    
eight year report 03/18/2022    
nine year report 03/18/2023    
10 year report 03/17/2024    
11 year report 03/18/2025    
Final Report 02/01/2026    


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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