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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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Fatigue Testing


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General
Study Status Completed
Application Number /
Requirement Number		 P070015 / PAS004
Date Original Protocol Accepted 07/02/2008
Date Current Protocol Accepted 07/02/2008
Study Name Fatigue Testing
Device Name XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
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 Objectives This is an implementation of updated final product testing methodologies.
Study Population N/A
Sample Size N/A
Key Study Endpoints 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 Results 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 Reporting Schedule

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


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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