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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 P130021 S002
Current Protocol Accepted 06/12/2014
Study Name ODE Lead-Continued f/u of the premarket cohorts
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Extended follow-up study of all available subjects that were enrolled in the Medtronic CoreValve® U.S.   show the rest ...
Study Population Description High risk and extreme risk subjects currently consented to and enrolled in the Medtronic U.S.   show the rest ...
Sample Size All available subjects enrolled in the US Pivotal Trial, 394 subjects randomized to transcatheter aortic   show the rest ...
Data Collection The primary endpoint of all-cause mortality at 12 months in High Risk subjects is non-inferior   show the rest ...
Followup Visits and Length of Followup Annually through 5 years

ODE Lead-Continued f/u of the premarket cohorts Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
one year report 01/17/2015 11/28/2014 On Time
two year report 01/17/2016 11/27/2015 On Time
three year report 03/17/2017    
four year report 03/16/2018    
five year report 03/16/2019    

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