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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHeartMate 3 Left Ventricular Assist System
Generic NameVentricular (assist) bypass
ApplicantABBOTT MEDICAL
6035 Stoneridge Dr.
Pleasanton, CA 94588
PMA NumberP160054
Supplement NumberS016
Date Received12/13/2018
Decision Date01/08/2019
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an additional Controller configuration with a lower Low Flow Hazard alarm threshold.
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