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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 drive
pleasanton, CA 94588
HDE NumberH070004
Supplement NumberS024
Date Received01/31/2020
Decision Date02/28/2020
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 
Approval for labeling changes that enhance the safety in use of the centrimag circulatory support system as a right ventricular assist system (rvas) for up to 30 days under approved humanitarian device exemption h070004.
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