f Post-Approval Studies (PAS) Database
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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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Wear testing


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General
Study Status Completed
Application Number /
Requirement Number		 P990046 / PAS001
Date Original Protocol Accepted 04/24/2009
Date Current Protocol Accepted 04/24/2009
Study Name Wear testing
Device Name ATS OPEN PIVOT BILEAFLET HEART VALVE
General Study Protocol Parameters
Study Design Bench/Lab Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Detailed Study Protocol Parameters
Study Objectives Bench study
Study Population Test valves: ATS Medical Open Pivot Bileaflet Mechanical Heart Valves, Model No.: 500DM21 and 500DM25.
Control valves: St. Jude Medical standard mechanical heart valves (Model No.: 21MJ-501 and 25MJ-501) of the same size as the test article.
Sample Size N/A
Key Study Endpoints n/a
Interim or Final Data Summary
Interim Results N/A, This is a bench testing study.
Actual Number of Patients Enrolled 10 mechanical prosthesis aortic valves tested including two control valves
Actual Number of Sites Enrolled Test sites; 2
Patient Follow-up Rate 100% at 0, 40, 80, 160, 400, 600 million cycles
Final Safety Findings Each of the tested valves shall have a minimum expected life due to mechanical wear of 100 in vivo years as extrapolated from the test results.
Final Effect Findings N/A
Study Strengths & Weaknesses The test is carried out based on ISO and FDA guidelines for mechanical prosthesis valves and fulfils the condition of approval. The results are supportive to the study purpose and meet the acceptation criteria per protocol.
Recommendations for Labeling Changes None


Wear testing Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
7 year report 02/12/2008 02/12/2008 On Time
1 year report 04/24/2010 04/23/2010 On Time
2 year report 04/24/2011 09/14/2011 Overdue/Received
chge in rpting timeline-3 year report 04/24/2012 12/04/2012 Overdue/Received
4 year report-400 million cycles 12/31/2013 12/16/2013 On Time
Final Report-600 million cycles 01/24/2015 02/27/2015 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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