|
Trade Name | DEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEM |
Applicant |
RELIANTHEART INC. |
8965 interchange drive |
houston, TX 77054 |
|
HDE Number | H030003 |
Supplement Number | S004 |
Date Received | 05/04/2005 |
Decision Date | 05/27/2005 |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change in the manufacturing process to propose an alternate supplier ofthe controller for the debakey vad controller. |