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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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Pipeline Flex Embolization w Shield Tech PAS


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General
Study Status Protocol Pending
Application Number P100018 S026/ PAS001
Study Name Pipeline Flex Embolization w Shield Tech PAS
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21


Pipeline Flex Embolization w Shield Tech PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/12/2021    
one year report 04/13/2022    
18 month report 10/12/2022    
two year report 04/13/2023    


Contact Us

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

Additional Resources

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