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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Centrimag PAS

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Study Status Completed
Application Number H070004 / PAS001
Date Current Protocol Accepted 05/22/2009
Study Name Centrimag PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
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 consecutive patients from the participating clinical centers with acute nght ventricular failure from any cause requiring use of the CentnMag RVAS to sustain life Patients may be enrolled from two populations The first population will include any patient in need of an RVAD that is not participating in the Levitronix

pivotal study entitled, "Levitronix CentnMag VAS Failure-to-Wean from Cardiopulmonary Bypass Trial" The second population will include patients who have been enrolled in the Levitronix pivotal trial and subsequently enrolled into this post approval study Patients enrolled in the pivotal study will already have a CentnMag RVAS in place
Study Population Description The study population includes patients implanted with the dentrimag device. The CentriMag RVAS is intended to provide temporary circulatory support for up to 14 days for patients in cardiogenic shock due to right ventricular failure. It is intended for use in patients with a body surface area of 1.4 m2 or greater.
Sample Size 25 consecutive patients implanted with the device will be followed from device implant to device removal, and 30 days post RVAD removal.
Data Collection The primary endpint in patients who recover and do not go on to transplantation or use of a long-term device includes survival to 30 days post-support or to hospital discharge, whichever is longer. In patients who do not recover and are bridged to transplant or a long-term system the primary endpoint is survival to induction of anesthesia for implantation of a long-term device or heart transplant.
Follow-up Visits and Length of Follow-up Clinical endpoints will be recorded at baseline, 3 days post-implant, prior to explant, and 30 days post-removal of the device.
Interim or Final Data Summary
Interim Safety Information There was no safety information presented.
Actual Number of Patients Enrolled 25
Actual Number of Sites Enrolled 9
Patient Follow-up Rate 100%
Final Safety Findings Central venous pressure, mean arterial pressure, and cardiac index increased a little on-pump, but returned to baseline by 2 days post쳌-pump.

BUN and total bilirubin increased on쳌-pump, but returned below baseline within 30 days post쳌-pump.

Final Effect Findings Success rate (Survival to 30 days, transplanted, or bridged to artificial heart): 72%
Study Strengths & Weaknesses Strengths: Prospective follow-up study 100% follow-up

Performance goal met by large margin

(72% vs. 10% performance goal) Weaknesses: None significant

Recommendations for Labeling Changes NONE

Centrimag PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's 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

Contact Us

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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