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Edwards eSheath+ Introducer Set
10058027001A_TH
S3PAS4045AP, 914ESP, 916ESP
Pulmonic
English
No
N/A
2023-08-29
Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent SAPIEN 3 THV with SAPIEN 3 Pulmonic Delivery System
10059845001A
S3PAS4045AP, 9600TFX29, 9630PL29, 9600CR
Pulmonic
English
No
N/A
2024-02-21
Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
10059844001A
S3PAS4045AP, 29AP4045
Pulmonic
English
No
N/A
2024-02-21
Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter HeartValve SystemEdwards SAPIEN 3, Edwards SAPIEN 3 Ultra, and Edwards SAPIEN 3 Ultra RESILIATranscatheter Heart ValveEdwards Commander Delivery System
10037624001A-MDR
S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, S3URCM20CE, S3URCM23CE, S3URCM26CE, S3URCM29CE, 9755RSL20, 9755RSL23, 9755RSL26, 9755RSL29, 9750TFX20, 9750TFX23, 9750TFX26, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750CM20, 9750CM23, 9750CM26, 9750CM29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR
MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral
English,
Czech - Česky,
Hungarian - Magyar
No
N/A
2023-11-03
Edwards SAPIEN 3 Transcatheter Heart Valve System Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Commander Delivery System
10051068002A - MDR_IL
S3TF320, S3TF323, S3TF326, S3TF329, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR
MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral
English,
Swedish - Svenska,
Danish - Dansk
No
N/A
2023-08-31
Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve SystemEdwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart ValveEdwards Commander Delivery System
10051087002A - MDR_IL
S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226, 9750TFX20, 9750TFX23, 9750TFX26, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR
MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral
English,
Swedish - Svenska,
Danish - Dansk
No
N/A
2023-08-31
Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve SystemEdwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart ValveEdwards Commander Delivery System
10051087002A - MDR_ZA
S3UCM220, S3UCM223, S3UCM226, 9750TFX20, 9750TFX23, 9750TFX26, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF320, S3TF323, S3TF326, S3TF329
MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral
English,
Swedish - Svenska,
Danish - Dansk
No
N/A
2023-08-31
Edwards eSheath+ Introducer Set
10056055001A - MDR_IL
914ESP, 916ESP, S3TF320, S3TF323, S3TF326, S3TF329, S3UCM220, S3UCM223, S3UCM226
MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral, MDR Pulmonic
English,
Swedish - Svenska,
Danish - Dansk
No
N/A
2023-08-31
Edwards eSheath+ Introducer Set
10056055001A - MDR_ZA
914ESP, 916ESP, S3UCM220, S3UCM223, S3UCM226, S3TF320, S3TF323, S3TF326, S3TF329
MDR LR and above aortic, MDR HR and above ViV, MDR THV-in-THV/SV aortic, MDR THV-in-SV mitral, MDR Pulmonic
English,
Swedish - Svenska,
Danish - Dansk
No
N/A
2023-08-31
Edwards SAPIEN 3 Transcatheter Heart Valve System Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Commander Delivery System Pulmonic Valve Implantation
10051243002A - MDR_IL
9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF320, S3TF323, S3TF326, S3TF329
MDR Pulmonic
English,
Swedish - Svenska,
Danish - Dansk
No
N/A
2023-08-29
IFUs and Operator Manuals are subject to change; the most current version is available on this site. If you do not find the document you need, or have difficulty accessing the document please contact Edwards Support at 1-888-570-4016 or at tech_support@edwards.com. To order a printed copy (free of charge) search for the desired IFU or Manual and use the shopping cart functionality.
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