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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 RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER AND CRIMPER
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Namereplacement heart valve
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP100041
Date Received11/01/2010
Decision Date11/02/2011
Product Code
NPT[ Registered Establishments with NPT ]
Docket Number 11M-0837
Notice Date 11/22/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00530894
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 
S027 S028 
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