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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
Classification Nameventricular (assist) bypass
Generic Nameventricular (assist) bypass
Applicant
Thoratec Corporation
6035 stoneridge drive
pleasanton, CA 94588
PMA NumberP160054
Supplement NumberS008
Date Received05/03/2018
Decision Date10/18/2018
Product Code
DSQ[ Registered Establishments with DSQ ]
Docket Number 18M-3983
Notice Date 10/23/2018
Advisory Committee Cardiovascular
Clinical Trials NCT02224755
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the HeartMate 3 Left Ventricular Assist System. The device is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in patients with advanced refractory left ventricular heart failure.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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