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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 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
Predetermined Change Control Plan AuthorizedNo
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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