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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 08/20/2012
Study Name OSB Lead-Enhanced Surveillance
Study Status Revised/Replaced Study
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 Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 2-armed (partially retrospective and partially prospective), multi-

center, non-randomized, cohort registry study that uses the INTERMACS   show the rest ...
Study Population Description Patients in the INTERMACS Registry who are implanted with the


Sample Size The study will be composed of 151 patients supported by the

Companion 2 Driver System and   show the rest ...
Data Collection Primary Endpoint

The primary endpoint parallels the study hypothesis: Transplant prior to three months, transfer to   show the rest ...
Followup Visits and Length of Followup 3 months, or when one of the primary endpoints is reached ¿ whichever occurs first.

Patients   show the rest ...

OSB Lead-Enhanced Surveillance Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
6 month report 11/14/2012 02/20/2013 Overdue/Received
one year report 05/16/2013 05/15/2013 On Time
18 month report-FINAL REPORT 12/16/2013 12/16/2013 On Time

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