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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Bench Testing


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General
Study Status Completed
Application Number /
Requirement Number		 P020026 / PAS001
Date Original Protocol Accepted 04/24/2003
Date Current Protocol Accepted 04/24/2003
Study Name Bench Testing
Device Name CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Interim or Final Data Summary
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
Final Effect Findings n/a
Study Strengths & Weaknesses n/a
Recommendations for Labeling Changes no


Bench Testing Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
5 year registry report 04/24/2007 05/01/2007 Overdue/Received
Duplicate Annual Report 05/01/2008 05/01/2008 On Time
6 year registry report 04/22/2009 04/20/2009 On Time
status report 05/06/2011 05/06/2011 On Time
7 year registry report-final 04/22/2012 07/03/2012 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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