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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 P070009
Current Protocol Accepted 09/09/2008
Study Name OSB Lead-Realize PAS
Study Status Progress Adequate
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 Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, single-arm, multi-center study designed to look at the long-term re-operation rates   show the rest ...
Study Population Description Study population: Subjects are between the ages of 18 and 60 years old who have   show the rest ...
Sample Size 300 patients, 8 sites
Data Collection The primary endpoint is the re-operation rate (including band revisions, band replacements, and explants) in   show the rest ...
Followup Visits and Length of Followup Subjects will be followed for five years. During year 1 following implant, evaluations take place   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 303
Actual Number of Sites Enrolled 8
Patient Followup Rate 77%
Final Safety Findings The primary safety goal of this study was to determine the reoperation rate (band revision,   show the rest ...
Final Effectiveness Findings As a result of the reduction in BMI, important and statistically significant reductions in the   show the rest ...
Study Strengths and Weaknesses Enrollment was successful: A sample size of 300 was expected and a total of 303   show the rest ...
Recommendations for Labeling Changes PAS study data must be added to the labeling including: description of the study design   show the rest ...

OSB Lead-Realize PAS Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
1 year report 09/27/2009 09/28/2009  
2 year report 09/27/2010 09/27/2010 On Time
3 year report 09/27/2011 09/26/2011 On Time
4 year report 09/26/2012 09/25/2012 On Time
5 year report 09/26/2013 09/26/2013 On Time
6 year report 09/26/2014 09/23/2014 On Time
final report 05/29/2015 05/29/2015 On Time
pages left out of final report 07/29/2015 07/29/2015 On Time

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