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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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SFA ISR IDE Continued f/u study

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Study Status Progress Adequate
Application Number P130024 S009/ PAS002
Study Name SFA ISR IDE Continued f/u study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21

SFA ISR IDE Continued f/u study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
interim report 10/11/2017 10/11/2017 On Time
one year report 02/07/2018 02/26/2018 Overdue/Received
two year report 02/07/2019   Overdue
three year report 02/07/2020    
four year report 02/06/2021    
five year report 02/06/2022    

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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