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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 | S005 |
Date Received | 08/19/2005 |
Decision Date | 09/13/2005 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a modification to the micromed debakey vado child system by adding a slip-on graft attachment to facilitate the placement of the outflow graftonto the pump outlet. |