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Trade Name | MICROMED HEART ASSIST 5 PEDIATRIC VAD LEFT VENTRICULAR ASSIST DEVICE |
Classification Name | ventricular (assist) bypass |
Generic Name | ventricular (assist) bypass |
Applicant |
RELIANTHEART INC. |
8965 interchange drive |
houston, TX 77054 |
|
HDE Number | H030003 |
Supplement Number | S010 |
Date Received | 05/26/2010 |
Decision Date | 10/01/2010 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the post-approval study protocol. |