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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 TRANSCATHETER HEART VALVE AND ACCESSORIES
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEDWARDS LIFESCIENCES LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP110021
Date Received05/02/2011
Decision Date10/19/2012
Withdrawal Date 03/18/2019
Product Code NPT 
Docket Number 12M-1088
Notice Date 11/07/2012
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH 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 VALVESTENOSIS 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. TRANSFEMORALTHE EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX, SIZES 23 MM AND 26 MM, ISINDICATED FOR TRANSFEMORAL DELIVERY IN PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVESTENOSIS WITHOUT SEVERE AORTIC INSUFFICIENCY AND WITH EJECTION FRACTION >20% WHO HAVE BEENEXAMINED BY A HEART TEAM INCLUDING AN EXPERIENCED CARDIAC SURGEON AND A CARDIOLOGIST AND FOUND TOEITHER BE: 1) INOPERABLE AND IN WHOM EXISTING CO-MORBIDITIES WOULD NOT PRECLUDE THE EXPECTEDBENEFIT 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 EDWARDSSAPIEN TRANSCATHETER HEART VALVE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 S031 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S044 S045 S046 S047 S048 S049 S050 S051 
S052 S053 S055 S056 
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