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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P110040
Current Protocol Accepted 09/19/2013
Study Name Complete SE SFA Long Term Study
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Study Objective
To evaluate the safety and effectiveness of the Complete SE SFA Stent System in   show the rest ...
Study Population Description All subjects with symptomatic ischemic PAD and above-the-knee lesions enrolled in the Complete SE SFA   show the rest ...
Sample Size 196 subjects enrolled at 28 sites in the US, Germany and Belgium.

Assumptions for sample   show the rest ...
Data Collection Primary endpoint: composite of freedom from acute death, amputation, and TLR events at 36 months.   show the rest ...
Followup Visits and Length of Followup 3 years post treatment
Final Study Results
Actual Number of Patients Enrolled 196

187 subjects were available at 12 months for follow-up though 36 month post procedure
Actual Number of Sites Enrolled 28 (23 in the United Sates and 5 in Belgium and Germany)
Patient Followup Rate 84.5% (131/151) at 36 months
Final Safety Findings Primary Endpoint
The event free major adverse event (MAE) rate (composite of acute death, target lesion   show the rest ...
Study Strengths and Weaknesses The study involved formal hypotheses testing and it met its primary endpoint at 36 months.

The   show the rest ...
Recommendations for Labeling Changes Labeling change is recommended to reflect the 3-year long term results from the post-approval study.   show the rest ...

Complete SE SFA Long Term Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
one year report-Final 10/20/2014 10/16/2014 On Time

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