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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 P130021
Most Recent Protocol Version Approved 01/10/2014
Study Name Continued f/u of continued access cohort
Study Status Study Pending
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 No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description A longitudinal observational clinical trial following subjects that were enrolled in the Medtronic CoreValve® Continued   show the rest ...
Study Population Description Extreme risk subjects currently consented to and enrolled in the Medtronic U.S. CAS Protocol, and   show the rest ...
Sample Size All subjects enrolled in the CoreValve® Continued Access Study (approximately 2250, including both ilio-femoral and   show the rest ...
Data Collection Primary endpoints: all-cause death or major stroke at 6 months and annually through 5 years.

Secondary   show the rest ...
Followup Visits and Length of Followup Annually through 5 years


Continued f/u of continued access cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
one year report 01/17/2015    
two year report 01/17/2016    
three year report 01/16/2017    
four year report 01/16/2018    
five year report 01/16/2019    

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