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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 P120020
Current Protocol Accepted 10/20/2014
Study Name SUPERB Extended F/U 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 No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of premarket cohorts
Study Population Description Subjects with SFA and proximal popliteal artery lesions treated with the Supera stent.

There is no   show the rest ...
Sample Size All remaining study subjects: 212 ITT subjects and 44 Roll-in

Subjects as of July 2013

  show the rest ...
Data Collection Safety Endpoint

Composite of amputation and clinically-driven target lesion revascularization (TLR) evaluated at 2 and 3   show the rest ...
Followup Visits and Length of Followup 3 years

2 and 3 years
Final Study Results
Actual Number of Patients Enrolled 264 subjects enrolled; 208 subjects were eligible for the 2-year PAS.
Actual Number of Sites Enrolled 46 Investigational Sites
Patient Followup Rate Follow-up rate- (ITT population) - Compliance rate at 36 months was 98.9% (177/179) Follow-up rate-   show the rest ...
Final Safety Findings (ITT Population)

Primary Endpoint

The long term composite safety endpoint of clinically driven TLR and Index limb   show the rest ...
Study Strengths and Weaknesses The study achieved adequate compliance rate at 3 years (98.9% for the ITT population)
Recommendations for Labeling Changes Labeling change is recommended to reflect the 3-year long term results from the post-approval study.   show the rest ...

SUPERB Extended F/U Study Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
final report 09/26/2014 11/17/2014 Overdue/Received
response to R1 RDEF-final report 05/15/2015 04/10/2015 On Time

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