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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 | S012 |
Date Received | 04/23/2013 |
Decision Date | 06/21/2013 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for hardware and software changes to the 2ndl generation centrimag primary console and mag monitor and is indicated for providing temporarycirculatory support for up to 30 days for patients in cardiogenic shock due to acute right ventricular failure. |