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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 P050019
Current Protocol Accepted 10/23/2008
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The CABANA study is a multi-center surveillance registry. The objectives of the registry are to:

1)   show the rest ...
Study Population Description The Carotid WALLSTENT Monorail Endoprosthesis, used in conjunction with the Boston Scientific embolic protection system,   show the rest ...
Sample Size 1,500 patients, 150 sites
Data Collection The endpoint for the 1,000 newly enrolled patients will be a 30-day composite death, stroke   show the rest ...
Followup Visits and Length of Followup Patients will be followed at 30 days and annually through 3 years.
Final Study Results
Actual Number of Patients Enrolled 1097
Actual Number of Sites Enrolled 99
Patient Followup Rate 95%
Final Safety Findings Of the 1,025 subjects evaluable for 30-day postprocedure MAE, 0.5% (5/1,025) had MIs, 3.3% (34/1,025)   show the rest ...
Final Effectiveness Findings The sponsor reports that system technical success was achieved in 97.1% of evaluable subjects.
Study Strengths and Weaknesses The sponsor reports good follow-up of study subjects. However, the study may not have been   show the rest ...
Recommendations for Labeling Changes Yes


Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 04/23/2009 04/22/2009 On Time
1 year report 10/23/2009 10/23/2009 On Time
18 month report 04/23/2010 04/20/2010 On Time
2 year report 10/23/2010 10/20/2010 On Time
final report 03/23/2011 03/23/2011 On Time

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