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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 NumberS006
Date Received03/27/2007
Decision Date05/16/2007
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 make modifications to the firmware of the patient home support system as listed in the hde supplement along with supporting changes inlabeling. Similarly, to incorporate other labeling changes to clarify some existing instructions and correct typographical errors.
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