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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 P110004 S001
Current Protocol Accepted 05/14/2015
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a prospective multi-center, non-randomized, single arm clinical study designed to collect and   show the rest ...
Study Population Description Patients with symptomatic ischemic heart disease due to a single de novo stenotic lesion contained   show the rest ...
Sample Size 131 patients enrolled from up to 15 sites in the USA.
Sample size assumptions
3-year TVF rate   show the rest ...
Data Collection Primary Endpoint
Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) [Q   show the rest ...
Followup Visits and Length of Followup Patients will be followed up for 3 years.
Follow-up will be performed at 30 days, 1,   show the rest ...


Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 06/19/2014 11/13/2014 Overdue/Received
one year report 12/19/2014 01/23/2015 Overdue/Received
18 month report 06/19/2015 07/21/2015 Overdue/Received
two year report 12/19/2015    
three year report 12/18/2016    
four year report 12/18/2017    
five year report 12/18/2018    

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