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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 NumberS020
Date Received03/01/2019
Decision Date06/04/2019
Product Code
OJE[ Registered Establishments with OJE ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for manufacturing sites located at pleasanton, california and burlington, massachusetts for servicing.
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