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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 NumberS003
Date Received03/09/2005
Decision Date06/14/2006
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 specific modifications (i. E. , joint between the inflow cannula and pump body and shortening of the extra-cardiac length by 0. 5 cm) to the micromeddebakey vad® child system.
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