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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE 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
Supplement NumberS002
Date Received10/20/2004
Decision Date04/29/2005
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for two design changes to the blood pump component of the device system. Specifically, to increase the gap between the rear face of the impeller and the leading edge of the rear diffuser and to increase the inlet angle (with respect to the vertical) of the diffuser leading edge.
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