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. |
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Trade Name | DEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEM |
Applicant |
RELIANTHEART INC. |
8965 interchange drive |
houston, TX 77054 |
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HDE Number | H030003 |
Supplement Number | S001 |
Date Received | 06/07/2004 |
Decision Date | 12/08/2004 |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Post-approval study of the micromed debakey vad child left ventricular assistsystem. |
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