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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 H070004
Current Protocol Accepted 05/22/2009
Study Name Centrimag PAS
Study Status Completed
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 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 prospective, one-armed, multi-center observational study. This study will include data from 25   show the rest ...
Study Population Description The study population includes patients implanted with the dentrimag device. The CentriMag RVAS is intended   show the rest ...
Sample Size 25 consecutive patients implanted with the device will be followed from device implant to device   show the rest ...
Data Collection The primary endpint in patients who recover and do not go on to transplantation or   show the rest ...
Followup Visits and Length of Followup Clinical endpoints will be recorded at baseline, 3 days post-implant, prior to explant, and 30   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 25
Actual Number of Sites Enrolled 9
Patient Followup Rate 100%
Final Safety Findings Central venous pressure, mean arterial pressure, and cardiac index increased a little on-pump, but returned   show the rest ...
Final Effectiveness Findings Success rate (Survival to 30 days, transplanted, or bridged to artificial heart): 72%
Study Strengths and Weaknesses Strengths: Prospective follow-up study 100% follow-up

Performance goal met by large margin

(72% vs. 10% performance goal) Weaknesses: None   show the rest ...
Recommendations for Labeling Changes NONE

Centrimag PAS Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
1 year report 10/07/2009 10/05/2009 On Time
18 month report 04/07/2010 04/06/2010 On Time
2 year report 10/07/2010 10/06/2010 On Time
3 year report 10/07/2011 10/07/2011 On Time
4 year report 10/06/2012 10/05/2012 On Time
54 month report 04/09/2013 04/08/2013 On Time
5 year report 10/06/2013 10/07/2013 Overdue/Received
66 month report 04/09/2014 04/09/2014 On Time
6 year report-Final 10/06/2014 10/07/2014 Overdue/Received

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