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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 (LVAS)
Generic NameVentricular (assist) bypass
ApplicantAbbott Medical
6035 Stoneridge Drive
Pleasanton, CA 94588
PMA NumberP160054
Supplement NumberS019
Date Received06/19/2019
Decision Date08/12/2019
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a manufacturing site located at Sterigenics in Salt Lake City, Utah for ethylene oxide sterilization of the HeartMate 3 LVAS and HeartMate II LVAS components.
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