PMA P140031S112

Device: EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System
Applicant: Edwards Lifesciences, LLC
Product code: NPT
Decision date: 2020-09-09
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: Approval for the Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System. This device is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or a surgical bioprosthetic mitral 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., predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Current openFDA PMA Record#

Device: EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S112
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2020-09-09
Decision code: APPR
Date received: 2020-03-16
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System. This device is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or a surgical bioprosthetic mitral 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., predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).