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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
Applicant
EDWARDS 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 Trials NCT01314313
Expedited Review Granted? No
Combination Product No
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:  S001 S002 S003 S004 S005 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S022 
S023 S024 S025 S026 S027 S028 S029 S031 S032 
S034 S035 S036 S037 S038 S039 S040 S041 S042 
S043 S044 S045 S046 S047 S048 S049 S050 S051 
S052 S053 S054 S055 S057 S058 S059 S060 S061 
S062 S063 S064 S065 S066 S067 S068 S069 S070 
S071 S072 S073 S074 S076 S077 S078 S079 S080 
S081 S082 S083 S084 S085 S086 S087 S088 S089 
S090 S091 S092 S093 S094 S095 S096 S097 S099 
S100 S101 S102 S103 S104 S105 S108 S109 S110 
S111 S112 S113 
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