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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 P070015
Current Protocol Accepted 07/02/2008
Study Name Dual Antiplatelet Therapy
Study Status Completed
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of this study is to evaluate the effectiveness and safety 12 versus 30   show the rest ...
Study Population Description The Xience V Everolimus Eluting Coronary Stent System was approved on July 2, 2008. This   show the rest ...
Sample Size Study Phase I (From index procedure to 1 year post stent implantation):8,000 patients, Study Phase   show the rest ...
Data Collection Annual rates of ST cardiac death and myocardial infarction will be determined.
Followup Visits and Length of Followup Annually to five years. Clinical follow-up will occur at 15, 24, 30 and 33 months.

Dual Antiplatelet Therapy Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
3 year report 07/02/2011 07/01/2011 On Time
4 year report 07/01/2012 07/02/2012 On Time
5 year report-final report 07/01/2013 02/28/2013 On Time

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