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Trade Name | DEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEM |
Classification Name | ventricular (assist) bypass |
Generic Name | ventricular (assist) bypass |
Applicant |
RELIANTHEART INC. |
8965 interchange drive |
houston, TX 77054 |
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HDE Number | H030003 |
Supplement Number | S009 |
Date Received | 03/15/2010 |
Decision Date | 04/15/2010 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |