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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 Dr.
Pleasanton, CA 94588
PMA NumberP060040
Supplement NumberS123
Date Received02/09/2026
Decision Date05/29/2026
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change of material of the contacts on the PCBA and Ribbon Cable Connector interface of the 11 Volt Backup Battery of the HeartMate II (HMII) and HeartMate 3 (HM3) System Controllers
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