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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 |
|
HDE Number | H070004 |
Supplement Number | S005 |
Date Received | 10/20/2009 |
Decision Date | 11/23/2009 |
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 a document, entitled "centrimag vas: patient and device management guidelines," to be included in the device shipping package. |