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Trade Name | LEVITRONIX CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS) |
Classification Name | right ventricular bypass (assist) device |
Generic Name | right ventricular bypass (assist) device |
Applicant |
Abbott |
6035 stoneridge drive |
pleasanton, CA 94588 |
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HDE Number | H070004 |
Supplement Number | S006 |
Date Received | 12/11/2009 |
Decision Date | 01/21/2010 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for consolidating the operating manuals for the centrimag rvas primary and back-up console; with those for use with other centrimagsystems under different regulatory statuses (ide ind 510(k)). |