Post-Approval Studies (PAS) Database

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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Registry-Based Real World use Surv of the Portico

General
Study Status	Study Pending
Application Number	P190023 / PAS002
Date Current Protocol Accepted	11/12/2021
Study Name	Registry-Based Real World use Surv of the Portico
General Study Protocol Parameters
Study Design	Comprehensive/Linked/RegistryBased Surveillance
Data Source	External Registry
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21

Registry-Based Real World use Surv of the Portico Schedule

Report Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	03/18/2022
1 year report	09/17/2022
18 month report	03/18/2023
2 year report	09/17/2023
3 year report	09/16/2024
4 year report	09/16/2025
5 year report	09/16/2026
6 year report	09/16/2027
7 year report	09/15/2028
final report	09/15/2029

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

Additional Resources

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