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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 Ventricular Assist System
Classification Nameright ventricular bypass (assist) device
Generic Nameright ventricular bypass (assist) device
Applicant
Abbott
6035 stoneridge dr.
pleasanton, CA 94588
HDE NumberH070004
Supplement NumberS045
Date Received02/02/2026
Decision Date04/17/2026
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 labeling changes to the centrimag motor instructions for use (ifu), centrimag blood pump ifu, and centrimag circulatory support system operation manual.
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