Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: HeartMate 3™ Left Ventricular Assist System
• Generic Name: Ventricular (assist) bypass
• Applicant: Abbott Medical; 6035 Stoneridge Drive; Pleasanton, CA 94588
• PMA Number: P160054
• Date Received: 12/05/2016
• Decision Date: 08/23/2017
• Product Code: DSQ
• Docket Number: 17M-5320
• Notice Date: 09/01/2017
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT02224755
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
Approval for the HeartMate 3 Left Ventricular Assist System. This device is indicated for providing short-term hemodynamic support (e.g., bridge to transplant or bridge to myocardial recovery) in patients with advanced refractory left ventricular heart failure.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Supplements: S011 S004 S005 S020 S021 S022 S023 S027 S028 S029 S036 ; S051 S038 S039 S040 S033 S053 S054 S059 S060 S061 S062 S008 ; S009 S010 S003 S006 S007 S001 S002 S012 S013 S015 S016 S030 ; S031 S017 S018 S024 S025 S026 S019 S014 S032 S048 S049 S055 ; S052 S034 S035 S050 S037 S047 S041 S042 S043 S044 S045 S068 ; S069 S070 S071 S072 S073 S075 S076 S077 S078 S063 S064 S065 ; S066 S056 S057 S058