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Sistema Edwards SAPIEN 3 UltraVálvula cardíaca transcateter Edwards SAPIEN 3 UltraSistema de colocação Edwards Commander
10052933001A
9750TFX20, 9750TFX23, 9750TFX26, 9610TF20, 9610TF23, 9610TF26, 9600CR, S3UCM220, S3UCM223, S3UCM226
LR and above (no ViV) aortic
Portuguese - Português
No
N/A
2022-10-13
Système de valves cardiaques transcathéter Edwards SAPIEN 3 et SAPIEN 3 Ultra Valves cardiaques transcathéter Edwards SAPIEN 3 et SAPIEN 3 Ultra Système de mise en place Edwards COMMANDER
10051088001A-MDR
S3TF320, S3TF323, S3TF326, S3TF329, S3UCM320, S3UCM323, S3UCM326, 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
French - Français,
Dutch - Nederlands,
German - Deutsch
No
N/A
2022-09-22
Edwards Transfemoral Balloon Catheter
10055129001A-MDD
9350BC16, 9350BC20, 9350BC23, 9350BC25, S3TF120, S3TF123, S3TF126, S3TF129
Pulmonic
English,
French - Français
No
N/A
2023-03-02
Système Edwards SAPIEN 3 Valve cardiaque transcathéter Edwards SAPIEN 3Système de mise en place Edwards Commander
10047272001A_TN
9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF120, S3TF123, S3TF126, S3TF129
Pulmonic
French - Français,
Dutch - Nederlands,
German - Deutsch
No
N/A
2021-06-04
Cathéter à ballonnet transfémoral Edwards
148111005A_TN
9350BC16, 9350BC20, 9350BC23, 9350BC25, S3TF120, S3TF123, S3TF126, S3TF129
Pulmonic
French - Français,
Dutch - Nederlands,
German - Deutsch
No
N/A
2021-06-25
Set d’introduction Edwards eSheath
149939004A_TN
9610ES14, 9610ES16, S3TF120, S3TF123, S3TF126, S3TF129
Pulmonic
French - Français,
Dutch - Nederlands,
German - Deutsch
No
N/A
2022-02-25
Edwards SAPIEN 3 Ultra SystemEdwards SAPIEN 3 Ultra Transcatheter Heart ValveEdwards Commander Delivery System
148439004B
9610TF20, 9610TF23, 9610TF26, 9750TFX20, 9750TFX23, 9750TFX26, 9600CR, S3UCM220, S3UCM223, S3UCM226
LR and above aortic
English,
Spanish - Español,
Portuguese - Português
No
N/A
2022-08-08
Edwards SAPIEN 3 Transcatheter Heart Valve System Edwards SAPIEN 3 Transcatheter Heart Valve Edwards COMMANDER Delivery System
10051068001A - MDR_IR
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
2022-09-19
Система сердечного клапана для чрескатетерного введения Edwards SAPIEN 3Сердечный клапан для чрескатетерного введения Edwards SAPIEN 3Система доставки Edwards COMMANDERИмплантация легочного клапана
10051252001A - MDR_TR
9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF320, S3TF323, S3TF326, S3TF329
MDR Pulmonic
Russian - Русский,
Turkish - Türkçe,
Croatian - Hrvatski
No
N/A
2022-09-12
eIFU ELK0-012-0531 KR
10053022001A
S3TF120, 9600TFX20, 9610ES14, 9350BC16, 9610TF20, 9600CR, S3TF123, 9600TFX23, 9350BC20, 9610TF23, S3TF126, 9600TFX26, 9350BC23, 9610TF26, S3TF129, 9600TFX29, 9610ES16, 9350BC25, 9610TF29
LR and above aortic, THV-in-SV aortic, THV-in-SV mitral
Korean – 한국어
No
N/A
2023-05-12
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