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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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TOBA II Continued f/u Study


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General
Study Status Progress Adequate
Application Number P180034 / PAS001
Study Name TOBA II Continued f/u Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, multi-center, single arm follow-up of the TOBA II pivotal study cohort studied under IDE G150029
Study Population Description Continued follow-up of the IDE cohort
Sample Size 204 remaining IDE subjects, active at the end of the 1-year evaluation
Data Collection Safety: Freedom from MAE at 30days compared to PG

Effectiveness: Primary patency at 12months compared to PG

Follow-up Visits and Length of Follow-up 3 years post-procedure


TOBA II Continued f/u Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/10/2019 10/10/2019 On Time
one year report 04/10/2020    
18 month report 10/09/2020    
two year report 04/10/2021    
three year report 04/10/2022    
four year report 04/10/2023    


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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