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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Nameaortic valve, prosthesis, percutaneously delivered
Applicant
EDWARDS LIFESCIENCES, LLC.
one edwards way
irvine, CA 92614
PMA NumberP130009
Supplement NumberS034
Date Received04/15/2015
Decision Date10/09/2015
Product Code
NPT[ Registered Establishments with NPT ]
Docket Number 15M-4017
Notice Date 11/03/2015
Advisory Committee Cardiovascular
Clinical Trials NCT01314313
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE SAPIEN XT TRANSCATHETER HEART VALVE, MODEL 9300TFX, AND ACCESSORIES. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO EITHER SEVERE NATIVE CALCIFIC AORTIC STENOSIS OR FAILURE (STENOSED, INSUFFICIENT, OR COMBINED) OF A SURGICAL BIOPROSTHETIC AORTIC VALVE 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
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