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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameLEVITRONIX CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS)
Classification Nameright ventricular bypass (assist) device
Generic Nameright ventricular bypass (assist) device
Applicant
Abbott
6035 stoneridge drive
pleasanton, CA 94588
HDE NumberH070004
Supplement NumberS012
Date Received04/23/2013
Decision Date06/21/2013
Product Code
OJE[ Registered Establishments with OJE ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
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.
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