f Post-Approval Studies (PAS) Database
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
  • Print
  • Share
  • E-mail
-

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.

Learn more...


           

Cont FU of Premarket Cohort-Durability II PAS


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Completed
Application Number /
Requirement Number		 P110023 / PAS002
Date Original Protocol Accepted 03/07/2012
Date Current Protocol Accepted 03/07/2012
Study Name Cont FU of Premarket Cohort-Durability II PAS
Device Name EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Interim or Final Data Summary
Actual Number of Patients Enrolled 287
Actual Number of Sites Enrolled 51
Patient Follow-up Rate 86%
Final Safety Findings Stent fracture rate at 3 years:0.9%
(Other key safety endpoints are subsumed in primary effectiveness endpoint (See below).
Final Effect Findings CDTLR at 3 years: 30%
Major amputation rate at 3 years: 0.8% Death rate at 30 days: 0%
Study Strengths & Weaknesses The main study limitations derive from the fact that the study population consisted of subjects from the premarket cohort. Premarket studies are typically characterized by providers who are exceptionally skilled, and are therefore likely to provide relatively good results. However, this study is just one component of a two-component PAS requirement. The other component, which is not yet completed, utilizes newly enrolled patients obtained from different sites, which are more likely to be typical of the general population of providers.
Recommendations for Labeling Changes yes


Cont FU of Premarket Cohort-Durability II PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/05/2012 08/24/2012 On Time
one year report 03/07/2013 02/26/2013 On Time
18 month report-final report 09/05/2013 10/02/2013 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

-
-