Post-Approval Studies (PAS)

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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Evolut R and PRO Sys Registry-Based Low Risk RWU

General
Study Status	Study Pending
Application Number	P130021 S058/ PAS002
Study Name	Evolut R and PRO Sys Registry-Based 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

Evolut R and PRO Sys Registry-Based Low Risk RWU Schedule

Report Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
one year report	01/15/2020
two year report	01/15/2021
three year report	01/15/2022
four year report	01/15/2023
five year report	01/15/2024
six year report	01/15/2025
seven year report	01/15/2026
eight year report	01/15/2027
nine year report	01/15/2028
ten year report	01/15/2029

Contact Us

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

Related Links

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order" - June 15, 2009
• PAS Database Background
• PAS FAQs