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Edwards SAPIEN 3 Ultra System Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Hear Valve Edwards Commander Delivery System
10053813001A_MDD/MDR
9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750TFX20, 9750TFX23, 9750TFX26, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF120, S3TF123, S3TF126, S3TF129, S3UCM220, S3UCM223, S3UCM226, S3TF320, S3TF323, S3TF326, S3TF329
LR and above aortic, THV-in-THV/SV aortic, THV-in-SV mitral
English
No
N/A
2023-05-31
Edwards SAPIEN 3 System Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Commander Delivery System
10055760001A_MDD/MDR
9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, S3TF120, S3TF123, S3TF126, S3TF129, 9600CR, S3TF320, S3TF323, S3TF326, S3TF329
Pulmonic
English
No
N/A
2023-05-31
Système de valves cardiaques transcathéters Edwards SAPIEN 3 et SAPIEN 3 Ultra Valves cardiaques transcathéters Edwards SAPIEN 3 et SAPIEN 3 Ultra Système de mise en place Edwards Certitude
10055165001C - MDR
S3TA320, S3TA323, S3TA326, S3TA329, S3USTA120, S3USTA123, S3USTA126, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750TFX20, 9750TFX23, 9750TFX26, 9620TA20, 9620TA23, 9620TA26, 9620TA29, 9630TA23, 9630TA26, 9600CR
MDR IR and above aortic, MDR HR and above ViV, MDR THV-in-SV/aortic, MDR THV-in-SV mitral
French - Français,
Dutch - Nederlands,
German - Deutsch
No
N/A
2024-03-13
Система сердечного клапана для чрескатетерного введения Edwards SAPIEN 3 и SAPIEN 3 Ultra Сердечный клапан для чрескатетерного введения Edwards SAPIEN 3 и SAPIEN 3 Ultra Система доставки Edwards Certitude
10055173001C - MDR
S3TA320, S3TA323, S3TA326, S3TA329, S3USTA120, S3USTA123, S3USTA126, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750TFX20, 9750TFX23, 9750TFX26, 9620TA20, 9620TA23, 9620TA26, 9620TA29, 9630TA23, 9630TA26, 9600CR
MDR IR and above aortic, MDR HR and above ViV, MDR THV-in-SV/aortic, MDR THV-in-SV mitral
Russian - Русский,
Turkish - Türkçe,
Croatian - Hrvatski
No
N/A
2024-03-13
Transkateetriga südameklapisüsteemid Edwards SAPIEN 3 ja SAPIEN 3 Ultra Transkateetriga südameklapid Edwards SAPIEN 3 ja SAPIEN 3 Ultra Paigaldussüsteem Edwards Certitude
10055172001C - MDR
S3TA320, S3TA323, S3TA326, S3TA329, S3USTA120, S3USTA123, S3USTA126, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750TFX20, 9750TFX23, 9750TFX26, 9620TA20, 9620TA23, 9620TA26, 9620TA29, 9630TA23, 9630TA26, 9600CR
MDR IR and above aortic, MDR HR and above ViV, MDR THV-in-SV/aortic, MDR THV-in-SV mitral
Estonian - Eesti,
Latvian - Latviešu,
Lithuanian - Lietuvių
No
N/A
2024-03-13
Σύστημα διακαθετηριακής καρδιακής βαλβίδας Edwards SAPIEN 3 και SAPIEN 3 Ultra Διακαθετηριακή καρδιακή βαλβίδα Edwards SAPIEN 3 και SAPIEN 3 Ultra Σύστημα τοποθέτησης Edwards Certitude
10055171001C - MDR
S3TA320, S3TA323, S3TA326, S3TA329, S3USTA120, S3USTA123, S3USTA126, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750TFX20, 9750TFX23, 9750TFX26, 9620TA20, 9620TA23, 9620TA26, 9620TA29, 9630TA23, 9630TA26, 9600CR
MDR IR and above aortic, MDR HR and above ViV, MDR THV-in-SV/aortic, MDR THV-in-SV mitral
Greek - ελληνικά,
Bulgarian - Български,
Romanian - Română
No
N/A
2024-03-13
Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Edwards Certitude Delivery System
10055170001C - MDR
S3TA320, S3TA323, S3TA326, S3TA329, S3USTA120, S3USTA123, S3USTA126, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750TFX20, 9750TFX23, 9750TFX26, 9620TA20, 9620TA23, 9620TA26, 9620TA29, 9630TA23, 9630TA26, 9600CR
MDR IR and above aortic, MDR HR and above ViV, MDR THV-in-SV/aortic, MDR THV-in-SV mitral
English,
Norwegian - Norsk,
Finnish - Suomi
No
N/A
2024-03-13
Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Edwards Certitude Delivery System
10055169001C - MDR
S3TA320, S3TA323, S3TA326, S3TA329, S3USTA120, S3USTA123, S3USTA126, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750TFX20, 9750TFX23, 9750TFX26, 9620TA20, 9620TA23, 9620TA26, 9620TA29, 9630TA23, 9630TA26, 9600CR
MDR IR and above aortic, MDR HR and above ViV, MDR THV-in-SV/aortic, MDR THV-in-SV mitral
English,
Spanish - Español,
Portuguese - Português
No
N/A
2024-03-13
Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Edwards Certitude Delivery System
10055168001C - MDR
S3TA320, S3TA323, S3TA326, S3TA329, S3USTA120, S3USTA123, S3USTA126, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750TFX20, 9750TFX23, 9750TFX26, 9620TA20, 9620TA23, 9620TA26, 9620TA29, 9630TA23, 9630TA26, 9600CR
MDR IR and above aortic, MDR HR and above ViV, MDR THV-in-SV/aortic, MDR THV-in-SV mitral
English,
Polish - Polski,
Slovak - Slovensky
No
N/A
2024-03-13
Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Edwards Certitude Delivery System
10055167001C - MDR
S3TA320, S3TA323, S3TA326, S3TA329, S3USTA120, S3USTA123, S3USTA126, 9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750TFX20, 9750TFX23, 9750TFX26, 9620TA20, 9620TA23, 9620TA26, 9620TA29, 9630TA23, 9630TA26, 9600CR
MDR IR and above aortic, MDR HR and above ViV, MDR THV-in-SV/aortic, MDR THV-in-SV mitral
English,
Czech - Česky,
Hungarian - Magyar
No
N/A
2024-03-13
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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