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Trade Name | 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 |
Date Received | 04/30/2007 |
Decision Date | 10/07/2008 |
Product Code | |
Docket Number | 08M0563 |
Advisory Committee |
Cardiovascular |
Supplement Type | hde original |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the centrimag® right ventricular assist system (rvas). This device is indicated for temporary circulatory support for up to 14 days for patients in cardiogenic shock due to acute right ventricular failure. |
Approval Order |
Approval Order
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Summary |
Summary of Safety and Probable Benefit
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Labeling |
Labeling
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Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S008 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S027 S028 S029 S030 S031 S032 S033 S034 |