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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.
 
DeviceSAPIEN 3 Ultra transcatheter heart valve
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP140031
Supplement NumberS085
Date Received04/01/2019
Decision Date08/16/2019
Product Code NPT 
Docket Number 19m-3845
Notice Date 08/16/2019
Advisory Committee Cardiovascular
Clinical TrialsNCT02675114
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System for expanding the indication to include patients at low risk for surgical aortic valve replacement. The devices are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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