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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 NumberS006
Date Received12/11/2009
Decision Date01/21/2010
Product Code
OJE[ Registered Establishments with OJE ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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)).
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