• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies

  • Print
  • Share
  • E-mail

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

Show All Studies
Suggest Enhancement / Report Issue | Export to ExcelExport to Excel
Application Number P010031 S232
Current Protocol Accepted 09/17/2012
Study Name OSB Lead-REVERSE Product Surveillance Registry
Study Status Progress Inadequate
Study Progress Reason Site enrollment milestones not met, Subject enrollment milestones not met
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 No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective cohort study
Study Population Description All adult patients treated with a Medtronic CRT-D device, meeting the expanded indication with QRS   show the rest ...
Sample Size 216 investigation sites, 500 patients
Data Collection ¿To estimate the 3-year survival probability of freedom from centrally adjudicated heart failure hospitalization or   show the rest ...
Followup Visits and Length of Followup 3 years, with the potential to be extended out to 5-years

every 6 months from implant   show the rest ...

OSB Lead-REVERSE Product Surveillance Registry Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 10/03/2012 10/03/2012 On Time
one year report 04/04/2013 04/01/2013 On Time
18 month report 10/03/2013 10/02/2013 On Time
two year report 04/04/2014 03/20/2014 On Time
three year report 04/04/2015 03/30/2015 On Time
four year report 04/03/2016 04/01/2016 On Time
five year report 04/03/2017    

Show All Studies