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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.

Links

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General
Application Number P060033
Most Recent Protocol Version Approved 09/16/2008
Study Name Registry PROTECT CA
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 Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The ENDEAVOR North America is a prospective, multi-center study intended to enroll a minimum of   show the rest ...
Study Population Description This device is indicated for improving coronary luminal diameter in patients with ischemic heart disease   show the rest ...
Sample Size 4,000 patients at 100-150 sites
Data Collection The primary endpoint is stent thrombosis and cardiac death plus myocardial infarction at 1 year.
Followup Visits and Length of Followup Follow up at: 1 month, 6 month, 12, 18, 24, 30, 36, 48, 60


Registry PROTECT CA Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
1 year report 01/31/2009 01/30/2009 On Time
18 month report 08/01/2009 07/30/2009 On Time
2 year report 01/31/2010 01/28/2010 On Time
3 year report 01/31/2011 01/28/2011 On Time
4 year report 01/31/2012 01/31/2012 On Time
5 year report 01/30/2013 01/30/2013 On Time
6 year report 01/30/2014 01/30/2014 On Time
7 year report-final report 03/31/2015    

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