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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 Drive
Pleasanton, CA 94588
PMA NumberP160054
Supplement NumberS039
Date Received09/27/2021
Decision Date03/24/2022
Product Code DSQ 
Advisory Committee Cardiovascular
Clinical TrialsNCT02224755
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for various updates to the Instructions for Use to add the final clinical results of the Long-Term Durability Cohort of the pivotal trial and of the post-approval study entitled "Continued Follow-up of the Continued Access Cohort."
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