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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.
 
DeviceEDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP130009
Date Received05/02/2013
Decision Date06/16/2014
Product Code NPT 
Docket Number 14M-0874
Notice Date 07/15/2014
Advisory Committee Cardiovascular
Clinical TrialsNCT01314313
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE SAPIEN XT TRANSCATHETER HEART VALVE (THV), MODEL 9300TFX, AND ACCESSORIES. THIS DEVICE IS INDICATED FOR RELIEF OF AORTIC STENOSIS IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO SEVERE NATIVE CALCIFIC AORTIC STENOSIS (AORTIC VALVE AREA <=1.0 CM2 OR AORTIC VALVE AREA INDEX <=0.6 CM2/M2, A MEAN AORTIC VALVE GRADIENT OF >= 40 MMHG, OR A PEAK AORTIC-JET VELOCITY OF >= 4.0 M/S), AND WITH NATIVE ANATOMY APPROPRIATE FOR THE 23, 26, OR 29 MM VALVE SYSTEM, WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT HIGH OR GREATER RISK FOR OPEN SURGICAL THERAPY (I.E., SOCIETY OF THORACIC SURGEONS OPERATIVE RISK SCORE >=8% OR AT A >=15% RISK OF MORTALITY AT 30 DAYS).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S035 S036 S022 S023 S024 S025 S026 S027 S055 S057 S058 
S059 S041 S042 S009 S010 S011 S045 S046 S047 S063 S069 S071 
S072 S073 S074 S012 S013 S014 S037 S038 S039 S040 S001 S028 
S029 S031 S032 S043 S044 S015 S016 S017 S018 S019 S002 S003 
S004 S005 S034 S048 S049 S050 S065 S051 S052 S053 S054 S078 
S079 S080 S081 S060 S061 S062 S070 S066 S067 S068 S064 S076 
S077 S084 S085 S092 S082 S108 S111 S099 S100 S101 S102 S095 
S083 S091 S089 S093 S090 S086 S087 S088 S094 S096 S097 S103 
S104 S105 S109 S110 S113 S112 
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