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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 II Left Ventricular Assist System
Generic NameVentricular (assist) bypass
ApplicantAbbott Medical
6035 Stoneridge Drive
Pleasanton, CA 94588
PMA NumberP060040
Supplement NumberS074
Date Received08/22/2019
Decision Date11/20/2019
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
Approval Order Statement  
Approval for various modifications to the labeling of the HeartMate 3 Left Ventricular Assist System and HeartMate II Left Ventricular Assist System regarding conformances to IEC 60601-1-2:2014 and IEC 60601-4-2:2016 standards.
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