f Post-Approval Studies (PAS) Database
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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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SE Persistent AF (PsAF) PAS


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General
Study Status Study Pending
Application Number /
Requirement Number
P130026 S070/ PAS001
Date Original Protocol Accepted 08/17/2022
Date Current Protocol Accepted  
Study Name SE Persistent AF (PsAF) PAS
Device Name TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21


SE Persistent AF (PsAF) PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 05/05/2022 07/20/2022 Overdue/Received
1 year report 11/04/2022 11/03/2022 On Time
18 month report 05/05/2023    
2 year report 11/04/2023    
3 year report 11/03/2024    
4 year report 11/03/2025    


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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