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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Cont f/u of the PORTICO IDE cohorts


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General
Study Status Ongoing
Application Number /
Requirement Number		 P190023 / PAS001
Date Original Protocol Accepted 09/17/2021
Date Current Protocol Accepted  
Study Name Cont f/u of the PORTICO IDE cohorts
Device Name Portico Transcatheter Aortic Valve Implantation System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21


Cont f/u of the PORTICO IDE cohorts Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 09/17/2022 09/14/2022 On Time
2 year report 09/17/2023 09/15/2023 On Time
3 year report 09/16/2024    
4 year report 09/16/2025    


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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