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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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Superion New Enrollment Study

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Study Status Progress Inadequate
Application Number P140004 / PAS002
Date Current Protocol Accepted 09/10/2019
Study Name Superion New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21

Superion New Enrollment Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 05/19/2016 05/20/2016 Overdue/Received
two year report 05/19/2017 05/19/2017 On Time
three year report 05/19/2018 05/21/2018 Overdue/Received
four year report 05/19/2019 05/20/2019 Overdue/Received
five year report 05/18/2020    

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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