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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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Training Study


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General
Study Status Completed
Application Number P040043 / PAS002
Date Original Protocol Accepted 08/31/2005
Study Name Training Study
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 Design Description This is an observational, multi-site, one armed prospective cohort study of patients with aneurysms treated with the TAG device.
Study Population Description The study will enroll subjects diagnosed with aneurysm of the DTA who meet all inclusion/exclusion criteria. Patients previously treated with the commercially approved TAG device by a physician who has completed the GORE TAG Physician Training program may be retrospectively screened for enrollment into this study.
Sample Size 150 patients from 25 sites
Data Collection The incidence of major adverse events at 30 days post-implant. Major Adverse Event are defined as those requiring therapy and short hospitalization (24-48 hours), major therapy, unplanned increase in level of care, prolonged hospitalization, permanent adverse sequelae, or death.
Follow-up Visits and Length of Follow-up Patients are evaluated at 30 days post-implant.
Interim or Final Data Summary
Interim Safety Information Study completed, see final results.
Actual Number of Patients Enrolled 150 patients
Actual Number of Sites Enrolled 25 sites
Patient Follow-up Rate 100%
Final Safety Findings All success criteria were met
Study Strengths & Weaknesses Strength: Very good patient follow-up; Data collection was complete
Label Changes None


Training Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
4 year report 03/22/2009 03/25/2009 Overdue/Received


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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