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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceHeartMate 3™ Left Ventricular Assist System
Generic NameVentricular (assist) bypass
ApplicantAbbott Medical
6035 Stoneridge Drive
Pleasanton, CA 94588
PMA NumberP160054
Date Received12/05/2016
Decision Date08/23/2017
Product Code DSQ 
Docket Number 17M-5320
Notice Date 09/01/2017
Advisory Committee Cardiovascular
Clinical TrialsNCT02224755
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements: S024 S012 S013 S034 S035 S038 S043 S044 S045 S051 S052 S053 
S054 S036 S033 S041 S042 S056 S057 S058 S059  S003 S001 
S002 S019 S025 S026 S032 S014 S015 S030 S031 S039 S040 S048 
S049 S050 S037 S047 S064 S065 S066 S055 S010 S004 S005 S011 
S006 S007 S008 S009 S017 S018 S022 S023 S016 S027 S028 S029 
S020 S021 S068 S070 S071 S060 S061 S062 S063 
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