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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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SAPIEN 3 Registry-Based Cont Access & Low Risk RWU


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General
Study Status Study Pending
Application Number P140031 S085/ PAS002
Study Name SAPIEN 3 Registry-Based Cont Access & Low Risk RWU
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21


SAPIEN 3 Registry-Based Cont Access & Low Risk RWU Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 09/01/2020    
two year report 09/01/2021    
three year report 09/01/2022    
four year report 09/01/2023    
five year report 09/01/2024    
six year report 09/01/2025    
seven year report 09/01/2025    
eight year report 09/01/2026    
nine year report 09/01/2027    
ten year report 09/01/2028    


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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