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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 (RVAS)
Classification Nameright ventricular bypass (assist) device
Generic Nameright ventricular bypass (assist) device
Applicant
Abbott
6035 stoneridge dr.
pleasanton, CA 94588
HDE NumberH070004
Supplement NumberS044
Date Received01/21/2026
Decision Date02/18/2026
Product Code
OJE[ Registered Establishments with OJE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Alternative manufacturing workflow for centrimag blood pump with receiving inspection and final packaging at abbott facilities.
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