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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 NumberS007
Date Received04/23/2008
Decision Date07/31/2008
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 to modify the "front hub" area of the debakey vad child and return the dacron textured "hat" of the inflow cannula to the former "long" configuration towhere the texturing extends to the inlet flare of the cannula.
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