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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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TactiFlex SE PAS


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General
Study Status Study Pending
Application Number /
Requirement Number
P220013 / PAS001
Date Original Protocol Accepted 06/25/2024
Date Current Protocol Accepted  
Study Name TactiFlex SE PAS
Device Name TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency Cable, Ampere™ Radiofrequency Generator, Cool Point Pump
Clinical Trial Number(s) NCT04356040 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Prospective, non-randomized, multi-center clinical investigation with no continued follow-up of IDE study subjects.
Study Population Subjects at least 18 years of age with paroxysmal atrial fibrillation (AF) that have tried and are refractory or intolerant to at least one Class I or III antiarrhythmic medication.
Key Study Endpoints Primary Effectiveness:
Freedom from AF recurrence post 90-day blanking period at 12 months.
Primary Safety:
Rate of device and/or procedure-related serious adverse events (SAE) within 3 months of the index ablation procedure.
Follow-up Visits and Length of Follow-up 12 months


TactiFlex SE PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/16/2023 11/17/2023 Overdue/Received
1 year report 05/17/2024 05/17/2024 On Time
18 month report 11/15/2024    
2 year report 05/17/2025    


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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