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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/Matter Testing


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General
Study Status Completed
Application Number /
Requirement Number		 P030025 S021/ PAS002
Date Original Protocol Accepted 09/24/2008
Date Current Protocol Accepted 09/24/2008
Study Name Fatigue/Matter Testing
Device Name TAXUS EXPRESS2 PACLITAXEL CORONARY STENT SYSTEM
General Study Protocol Parameters
Study Design Bench/Lab 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 Objectives This is a simulated use particulates testing, 10-year equivalent pulsatile particulates on a curve testing, 10-year equivalent pulsatile fatigue on a curve testing.
Study Population N/A
Sample Size N/A
Key Study Endpoints This is a simulated use particulates testing, 10-year equivalent pulsatile particulates on a curve testing, 10-year equivalent pulsatile fatigue on a curve testing.
Follow-up Visits and Length of Follow-up N/A
Interim or Final Data Summary
Interim Results N/A, This is a bench testing study.
Actual Number of Patients Enrolled NA
Actual Number of Sites Enrolled NA
Patient Follow-up Rate NA
Final Safety Findings NA
Final Effect Findings NA
Study Strengths & Weaknesses NA
Recommendations for Labeling Changes None


Fatigue/Matter Testing Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 09/24/2009 10/28/2009 Overdue/Received


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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