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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 P030011 S011
Current Protocol Accepted 11/27/2015
Study Name OSB Lead-INTERMACS Companion
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source External Registry
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a two쳌]armed (partially retrospective and partially prospective), multi쳌]center, non쳌] randomized, cohort registry study   show the rest ...
Study Population Description Patients in the INTERMACS Registry who are implanted with the

TAH쳌]t and used the C2 Driver   show the rest ...
Sample Size The study will be composed of 200 patients supported by the Companion 2 Driver System   show the rest ...
Data Collection The primary endpoint is survival rate, defined as noted above for the study hypotheses.
Followup Visits and Length of Followup 4 years

Per INTERMACS Registry (1 week, 1 month, 3 month, 6 month and every 6   show the rest ...

OSB Lead-INTERMACS Companion Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 06/24/2014 06/24/2014 On Time
one year report 02/11/2015 02/18/2015 Overdue/Received
18 month report 06/24/2015 06/24/2015 On Time
two year report 01/25/2016 01/27/2016 Overdue/Received
three year report 12/24/2016    
four year report 12/24/2017    

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