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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 dr.
houston, TX 77054
HDE NumberH030003
Supplement NumberS005
Date Received08/19/2005
Decision Date09/13/2005
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 a modification to the micromed debakey vado child system by adding a slip-on graft attachment to facilitate the placement of the outflow graftonto the pump outlet.
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