f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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Long Term


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General
Study Status Completed
Application Number /
Requirement Number		 P030011 / PAS001
Date Original Protocol Accepted 10/15/2004
Date Current Protocol Accepted 01/04/2011
Study Name Long Term
Device Name SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives .Enhanced surveillance of all device usage.
Study Population No human subjects will be enrolled in this enhanced surveillance of the Companion 2 Driver System Study. The data for this study are being collected under an existing procedure for reporting and assessing Customer Experiences relating to all SynCardia devices being used globally.
Sample Size This surveillance study will be conducted over one year commencing with the first use of the Companion 2 Driver System after study initiation and continued for one year with no specified sample size. It is anticipated that the Companion 2 Driver System will be used approximately 100 times in the United States during the one year duration of this study.
Key Study Endpoints 1. Number of times the Companion 2 Driver System is used to support a patient during the study period. (Each time a patient is transferred to a Companion 2 Driver System will count as one use.)
2. Number of Customer Experiences related to the Companion 2 Driver System or its accessories submitted during the study period.
3. Number of Customer Experiences related to the Companion 2 Driver system or its accessories that involved human factors submitted during the study period.
4. Types of identified human factors, severity of impact to patient care, and frequency of occurrence, will be calculated across all sites and by individual site.
Follow-up Visits and Length of Follow-up Not applicable
Not applicable


Long Term Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 10/15/2005 10/17/2005 Overdue/Received
2 year report 10/15/2006 10/16/2006 Overdue/Received
3 year report 10/15/2007 10/17/2007 Overdue/Received
4 year report 10/14/2008 10/14/2008 On Time
5 year report 10/14/2009 10/15/2009 Overdue/Received
6 year report 10/14/2010 10/15/2010 Overdue/Received
72 month report 10/13/2011 10/13/2011 On Time
84 month report 01/13/2013 01/11/2013 On Time
96 month report 10/15/2013 10/15/2013 On Time
9 year report 10/15/2014 10/09/2014 On Time
Final Report 06/25/2015 06/25/2015 On Time
response to R29 RDEF-final report 12/09/2015 12/10/2015 Overdue/Received


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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