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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 NameCentriMag Right Vascular Assist System (RVAS)/CentriMag Circulatory Support System
Classification Nameright ventricular bypass (assist) device
Generic Nameright ventricular bypass (assist) device
Applicant
Abbott
6035 stoneridge drive
pleasanton, CA 94588
HDE NumberH070004
Supplement NumberS022
Date Received09/03/2019
Decision Date10/03/2019
Product Code
OJE[ Registered Establishments with OJE ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
The addition of 3 warnings to be added to the device labeling.
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