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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 NumberS009
Date Received03/15/2010
Decision Date04/15/2010
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for cheanging the device trade name from the debakey vad® child l-eft ventricular assist device to 1-i -artassist® 5 pediatric vad. The device, asmodified, will he marketed under the trade name heartassist® 5 pediatric vad and is indicated for use to provide temporary left side mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients (5-16 yeas old, with bsa > 0. 7 m ~and < 1. 5 1in 2) who are in nyha class iv end stage heart failure, are refractory to medical therapy and \vho are (listed) candidates for cardiac transplantation.
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