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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.
 
Trade NameEDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Namereplacement heart valve
ApplicantEDWARDS LIFESCIENCES LLC.
PMA NumberP110021
Date Received05/02/2011
Decision Date10/19/2012
Product Code
NPT[ Registered Establishments with NPT ]
Docket Number 12M-1088
Notice Date 11/07/2012
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for edwards sapien¿ transcatheter heart valve model 9000tfx, sizes 23mm and 26mm, and transapical and transfemoral accessories listed above. This device is indicated for the following: transapical - the edwards sapien transcatheter heart valve, model 9000tfx, sizes 23 mm and 26 mm, is indicated for transapical delivery in patients with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction >= 20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to be operative candidates for aortic valve replacement but who have a society of thoracic surgeons operative risk score >= 8% or are judged by the heart team to be at a >=15% risk of mortality for surgical aortic valve replacement. The ascendra balloon catheter is indicated for the transapical delivery of the edwards sapien transcatheter heart valve. Transfemoral the edwards sapien transcatheter heart valve, model 9000tfx, sizes 23 mm and 26 mm, is indicated for transfemoral delivery in patients with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction >20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to either be: 1) inoperable and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis; or 2) be operative candidates for aortic valve replacement but who have a society of thoracic surgeons predicted operative risk score > 8% or are judged by the heart team to be at a >15% risk of mortality for surgical aortic valve replacement. The retroflex 3 delivery system is indicated for the transfemoral delivery of the edwards sapien transcatheter heart valve.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S033 S034 S035 S036 
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