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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1ml Magtrace w Sentimag PAS


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General
Study Status Study Pending
Application Number /
Requirement Number		 P160053 S009/ PAS001
Date Original Protocol Accepted 06/07/2024
Date Current Protocol Accepted  
Study Name 1ml Magtrace w Sentimag PAS
Device Name Magtrace and Sentimag Magnetic Localization System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21


1ml Magtrace w Sentimag PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/15/2024    
1 year report 04/15/2025    
18 month report 10/15/2025    
2 year report 04/15/2026    
3 year report 04/15/2027    


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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