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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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PAS-Post-Market Surveillance Study/LongTerm Safety


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General
Study Status Protocol Overdue
Application Number P170013 / PAS001
Study Name PAS-Post-Market Surveillance Study/LongTerm Safety
General Study Protocol Parameters


PAS-Post-Market Surveillance Study/LongTerm Safety Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/28/2018 11/29/2018 Overdue/Received
one year report 05/30/2019 05/29/2019 On Time
18 month report 11/28/2019    
two year report 05/29/2020    
three year report 05/29/2021    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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