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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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Registry-Based Real World use Surv of the Portico

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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
Date Due
FDA Receipt
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

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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