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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 P060027
Current Protocol Accepted 10/31/2008
Study Name Long Term
Study Status Other
Study Progress Reason Device not marketed
General Study Protocol Parameters
Study Design Prospective & Retrospective 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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The post-approval study is a 5-year, multi-center, single arm, prospective and retrospective cohort study. All   show the rest ...
Study Population Description Study population same as approved product. Indication for use: Ovatio cardiac resynchronization therapy is indicated   show the rest ...
Sample Size 2260 subjects, 20 sites
Data Collection Endpoints include complication free rate at 5 years, individual adverse event rates through 5 years,   show the rest ...
Followup Visits and Length of Followup Scheduled follow-up occurs at discharge, one month, 6 months, and every 6 months thereafter, for   show the rest ...

Long Term Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
Fatigue Test Report 06/02/2008 06/02/2008 On Time
6 Month Report 04/13/2009 05/01/2009 Overdue/Received
1 Year Report 10/30/2009 10/30/2009 On Time
18 Month Report 04/13/2010 04/14/2010 Overdue/Received
2 Year Report 10/15/2010 10/20/2010 Overdue/Received
30 month report 04/13/2011 04/14/2011 Overdue/Received
3 Year Report 10/14/2011 10/14/2011 On Time
42 month report 04/13/2012 04/13/2012 On Time
4 Year Report 10/15/2012 10/15/2012 On Time

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