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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 NumberP100041
Date Received11/01/2010
Decision Date11/02/2011
Withdrawal Date 03/18/2019
Product Code NPT 
Docket Number 11M-0837
Notice Date 11/22/2011
Advisory Committee Cardiovascular
Clinical TrialsNCT00530894
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX, SIZES 23MM AND 26MM AND ACCESSORIES. THIS DEVICE IS INDICATED FOR TRANSFEMORAL DELIVERY IN PATIENTS WITH SEVERE SYMPTOMATIC NATIVE AORTIC VALVE STENOSIS WHO HAVE BEEN DETERMINED BY A CARDIAC SURGEON TO BE INOPERABLE FOR OPEN AORTIC VALVE REPLACEMENT AND IN WHOM EXISTING COMORBIDITIES WOULD NOT PRECLUDE THE EXPECTED BENEFIT FROM CORRECTION OF THE AORTIC STENOSIS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S058 S023 S024 S027  S053 S016 S017 S018 S062 S063 S064 
S046 S029 S030 S031 S055 S056 S013 S007 S008 S001 S002 S039 
S040 S041 S042 S043 S044 S047 S048 S049 S059 S019 S020 S021 
S022 S065 S066 S014 S028 S054 S009 S010 S011 S012 S003 S004 
S005 S006 S060 S061 S032 S033 S034 S035 S036 S050 S051 S052 
S015 S037 S038 S068 S069 
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