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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 P060025
Current Protocol Accepted 10/13/2015
Study Name OSB Lead-ATS 3f
Study Status Other
Study Progress Reason Device not marketed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source Sponsor Registry
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 This is a multi-center, non-randomized trial, registry study designed to follow at least 101 patients   show the rest ...
Study Population Description For patients undergoing isolated aortic valve replacement of his / her native aortic valve, or   show the rest ...
Sample Size 101 patients 70 years of age or less across 8 sites
Data Collection Hemodynamic performance, specifically the proportion of regurgitation, will be used to evaluate the safety of   show the rest ...
Followup Visits and Length of Followup Patients will be enrolled and followed preoperative, operative, at discharge (or postoperatively at less than   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 34; There were 26 eligible subjects implanted with the Model 1000 valve including 14 prospectively   show the rest ...
Actual Number of Sites Enrolled 8
Patient Followup Rate 90.9% at 4 years, 85.7% at 5 years
Final Safety Findings Adjudicated Events

Non Structural dysfunction 3, major perivalvular leak 3, Structural valve deterioration 2, Thromboembolism 5,   show the rest ...
Final Effectiveness Findings Six (6) of 26 (23.1%) study subjects, experienced aortic regurgitation (AR) of moderate or greater   show the rest ...
Study Strengths and Weaknesses The study experienced difficulty with recruiting eligible subjects
Recommendations for Labeling Changes None

OSB Lead-ATS 3f Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 mth report 02/12/2010 02/04/2010 On Time
1 year report 08/12/2010 08/04/2010 On Time
18 mnth report 02/14/2011 02/11/2011 On Time
2 year report 08/12/2011 08/11/2011 On Time
30 month report 02/14/2012 02/14/2012 On Time
3 year report 08/13/2012 08/09/2012 On Time
42 month report 02/12/2013 02/08/2013 On Time
4 year report 08/12/2013 08/09/2013 On Time
54 month report 02/12/2014 02/07/2014 On Time
5 year report 08/12/2014 08/12/2014 On Time
66 month report 02/12/2015 02/12/2015 On Time
6 year report 08/12/2015 08/12/2015 On Time
Final Report 01/13/2016 01/13/2016 On Time

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