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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 LVAS
Generic NameVentricular (assist) bypass
ApplicantABBOTT MEDICAL
6035 Stoneridge Dr.
Pleasanton, CA 94588
PMA NumberP060040
Supplement NumberS065
Date Received01/04/2017
Decision Date06/30/2017
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to revise the Instruction for Use (IFU) for the HeartMate II LVAS to include a summary of results from the PREVENT post-market study, post-approval rates of pump thrombosis, and changes to the clinical management guidelines.
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