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Edwards SAPIEN XT Transcatheter Heart Valve with the NovaFlex+ Delivery System
10001249002A
9355FS23, 9355FS26, 9355FS29, 9300TFX23, 9300TFX26, 9300TFX29
Pulmonic
English
No
2017-07-14
Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery System
158501004A
9355AS23, 9355AS26, 9355AS29, 9300TFX23, 9300TFX26, 9300TFX29
HR and above aortic ViV, HR and above symptomatic aortic
English
No
2017-07-14
Edwards Alterra Adaptive Prestent System
10043119003A
29AP4045
Pulmonic
English
No
2025-02-20
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve SAPIEN 3 Ultra Delivery System
10042990001A
9630TF20, 9630TF23, 9630TF26, 9630TF29, 9750TFX20, 9750TFX23, 9750TFX26, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29
LR and above symptomatic aortic, HR and above aortic ViV, THV-in-SV HR and above mitral
English
No
2020-09-11
Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Edwards Certitude Delivery System
10033860008A
9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9600IS18, 9600IS21, 9630TA20, 9630TA23, 9630TA26, 9630TA29, 9750TFX20, 9750TFX23, 9750TFX26
LR and above symptomatic aortic, HR and above aortic ViV, THV-in-THV/SV HR aortic, THV-in-SV HR and above mitral
English
No
2021-09-22
Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, and Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Edwards Commander Delivery System
10033859014B
9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750TFX20, 9750TFX23, 9750TFX26, 9750CM20, 9750CM23, 9750CM26, 9750CM29
LR and above symptomatic/ asymptomatic severe aortic stenosis, HR and above aortic ViV, THV-in-THV/SV HR aortic, HV-in-SV MR and above mitral
English
No
2025-05-07
Edwards Crimper Model 9350CR
157566001A
9350CR
English
No
2017-07-14
Edwards SAPIEN XT Transcatheter Heart Valve with the NovaFlex+ Delivery System
157563004A
9355FS23, 9355FS26, 9355FS29, 9300TFX23, 9300TFX26, 9300TFX29
HR and above aortic ViV, HR and above symptomatic aortic
English
No
2017-07-14
Edwards eSheath+ Introducer Set
10063017001A_IL
914ESP, 916ESP, S3PAS4045EA, S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, S3URCM20EA, S3URCM23EA, S3URCM26EA, S3URCM29EA
MDR Pulmonic, MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral
English
No
N/A
2025-02-11
Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent SAPIEN 3 THV with SAPIEN 3 Pulmonic Delivery System
10059845002A_IL
S3PAS4045EA, 9600TFX29, 9630PL29, 9600CR
Pulmonic
English
No
N/A
2025-04-29
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