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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Nameaortic valve, prosthesis, percutaneously delivered
one edwards way
irvine, CA 92614
PMA NumberP130009
Date Received05/02/2013
Decision Date06/16/2014
Product Code
NPT[ Registered Establishments with 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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