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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEM
Classification Nameventricular (assist) bypass
Generic Nameventricular (assist) bypass
Applicant
RELIANTHEART INC.
8965 interchange drive
houston, TX 77054
HDE NumberH030003
Date Received07/29/2003
Decision Date02/25/2004
Product Code
DSQ[ Registered Establishments with DSQ ]
Docket Number 04M-0090
Advisory Committee Cardiovascular
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the debakey vad® child left ventricular assist system. This device is indicated for use to provide temporary left side mechanical circulatory support as a bridge to cardiac transplantaion for pediatric patients (5-16 years old, with bsa ?0. 7m2 and <1. 5m2) who are in nyha class iv end stage heart failure, are refractory to medical therapy and who are (listed) candidates for cardiac transplantation.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
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