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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
Applicant
Reliantheart, Inc.
8965 interchange dr.
houston, TX 77054
HDE NumberH030003
Supplement NumberS001
Date Received06/07/2004
Decision Date12/08/2004
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason other
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Post-approval study of the micromed debakey vad child left ventricular assistsystem.
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