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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 (LVAS)
Generic NameVentricular (assist) bypass
ApplicantABBOTT MEDICAL
6035 Stoneridge Dr.
Pleasanton, CA 94588
PMA NumberP060040
Supplement NumberS124
Date Received03/12/2026
Decision Date06/10/2026
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for alternate connector components for the connection interface between the user interface (UI) membrane and the main printed circuit board assembly (PCBA) of the HeartMate II (HMII) System Controller and HeartMate 3 (HM3) System Controller.
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