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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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Solia S LBBA EP PASSION


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General
Study Status Study Pending
Application Number /
Requirement Number
P950037 S255/ PAS001
Date Original Protocol Accepted 10/11/2024
Date Current Protocol Accepted  
Study Name Solia S LBBA EP PASSION
Device Name Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P), Pulse Generator, Permanent, Implantable, Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes
Clinical Trial Number(s) NCT04323670   NCT05251363  
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21


Solia S LBBA EP PASSION Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 02/28/2025    
1 year report 08/30/2025    
18 month report 02/28/2026    
2 year report 08/30/2026    
30 month report 02/28/2027    
3 year report 08/30/2027    


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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