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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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Fatigue Testing

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Study Status Completed
Application Number P070015 / PAS004
Date Current Protocol Accepted 07/02/2008
Study Name Fatigue Testing
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is an implementation of updated final product testing methodologies.
Study Population Description N/A
Sample Size N/A
Data Collection This is an implementation of updated final product testing methodologies.
Follow-up Visits and Length of Follow-up N/A
Interim or Final Data Summary
Interim Safety Information Study completed, see final results.
Actual Number of Patients Enrolled N/A
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A
Final Safety Findings N/A This is a bench testing study.
Study Strengths & Weaknesses N/A
Recommendations for Labeling Changes N/A

Fatigue Testing Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
Final Embolic Coating Fatigue Report 03/09/2009 03/09/2009 On Time

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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