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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 Transcatheter Heart Valve SystemEdwards SAPIEN 3 Transcatheter Heart Valve Edwards COMMANDER Delivery SystemPulmonic Valve Implantation
10051243001A - MDR_TH
9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF320P, S3TF323P, S3TF326P, S3TF329P
MDR Pulmonic
English,
Swedish - Svenska,
Danish - Dansk
No
N/A
2022-09-12
Edwards eSheath Introducer Set
10051253001A - MDR_TH
9610ES14, 9610ES16, S3TF320P, S3TF323P, S3TF326P, S3TF329P
MDR Pulmonic
English,
Swedish - Svenska,
Danish - Dansk
No
N/A
2022-08-16
Edwards eSheath Introducer Set
149943004A_MX
9610ES14, 9610ES16, S3TF120, S3TF123, S3TF126, S3TF129, S3UCM220, S3UCM223, S3UCM226
LR and above aortic, HR and above ViV, THV-in-THV/SV aortic, THV-in-SV mitral, Pulmonic
English,
Spanish - Español,
Portuguese - Português
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
eIFU ELK0-012-0531 S3U KR
10052410001B
9750TFX20, 9750TFX23, 9750TFX26, 9610TF20, 9610TF23, 9610TF26, 9610ES14, 9600CR, S3UCM220, S3UCM223, S3UCM226
LR and above aortic, THV-in-SV aortic, THV-in-SV mitral
Korean – 한국어
No
N/A
2023-05-12
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