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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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Popliteal Indication PAS Surv Project


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General
Study Status Progress Adequate
Application Number P070014 S037/ PAS001
Date Current Protocol Accepted  
Study Name Popliteal Indication PAS Surv Project
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21


Popliteal Indication PAS Surv Project Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/29/2016 12/01/2016 Overdue/Received
one year report 05/31/2017 06/01/2017 Overdue/Received
18 month report 11/29/2017 12/01/2017 Overdue/Received
two year report 05/31/2018 05/31/2018 On Time
three year report 05/31/2019    
Final Report 03/31/2020    


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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