f Post-Approval Studies (PAS) Database
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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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INSPIRE Pipeline Vantage Embolization Device PAS


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General
Study Status Protocol Overdue
Application Number /
Requirement Number		 P100018 S034/ PAS001
Study Name INSPIRE Pipeline Vantage Embolization Device PAS
Device Name Pipeline Vantage Embolization Device with Shield Technology
General Study Protocol Parameters


INSPIRE Pipeline Vantage Embolization Device PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/15/2024 03/15/2024 On Time
1 year report 09/14/2024    
18 month report 03/15/2025    
2 year report 09/14/2025    
3 year report 09/14/2026    
4 year report 09/14/2027    


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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