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Sisestuskomplekt Edwards eSheath
149946004A-MDD
9610ES14, 9610ES16, S3TF120, S3TF123, S3TF126, S3TF129, S3UCM220, S3UCM223, S3UCM226
LR and above aortic (no ViV), LR and above aortic, HR and above ViV, THV-in-THV/SV aortic, THV-in-SV mitral
Estonian - Eesti,
Latvian - Latviešu,
Lithuanian - Lietuvių
No
N/A
2022-02-25
Edwards SAPIEN 3 Ultra SystemEdwards SAPIEN 3 Ultra Transcatheter Heart ValveEdwards COMMANDER Delivery System
148436005A_MDD
9750TFX20, 9750TFX23, 9750TFX26, 9610TF20, 9610TF23, 9610TF26, 9600CR, S3UCM220, S3UCM223, S3UCM226
LR and above aortic
English,
Swedish - Svenska,
Danish - Dansk
No
N/A
Edwards Transfemoral Balloon Catheter
149933004A_EC
9350BC20, 9350BC23, 9350BC25, S3TF123, S3TF126, S3TF129
LR and above aortic, HR and above ViV, THV-in-THV/SV aortic, THV-in-SV mitral
English,
Spanish - Español,
Portuguese - Português
No
N/A
2019-06-12
Symbol Legend Addendum
10053179001A_APAC
9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, 9610ES14, 9610ES16, 9350BC16, 9350BC20, 9350BC23, 9350BC25, S3TF120, S3TF123, S3TF126, S3TF129
LR and above aortic, HR and above ViV, THV-in-THV/SV aortic, THV-in-SV mitral
English
No
N/A
2022-07-27
Symbol Legend Addendum
10053179001A_AU
9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9750TFX20, 9750TFX23, 9750TFX26, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, 9610ES14, 9610ES16, 9350BC16, 9350BC20, 9350BC23, 9350BC25
LR and above (no ViV) aortic
English
No
N/A
2022-07-27
Symbol Legend Addendum
10053179001A_NZ
9610ES14, 9610ES16
LR and above aortic, HR and above ViV, THV-in-THV/SV aortic, THV-in-SV mitral
English
No
N/A
2022-03-04
Symbol Legend Addendum
10053179001A_IN
9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, 9610ES14, 9610ES16, 9350BC16, 9350BC20, 9350BC23, 9350BC25, S3TF120, S3TF123, S3TF126, S3TF129
Aortic, Valve-in-Valve
English
No
N/A
2022-07-27
Système Edwards SAPIEN 3Valve cardiaque transcathéter Edwards SAPIEN 3Système de mise en place Edwards CommanderTransfémoral
10037018003A
9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF120, S3TF123, S3TF126, S3TF129
LR and above aortic, HR and above ViV, THV-in-THV/SV aortic, THV-in-SV mitral
French - Français,
Dutch - Nederlands,
German - Deutsch
No
N/A
2022-02-23
Kit Edwards SAPIEN 3 – Transfémoral
148157004
9600TFX20, 9600TFX23, 9600TFX26, 9600TFX29, 9610TF20, 9610TF23, 9610TF26, 9610TF29, 9600CR, S3TF120, S3TF123, S3TF126, S3TF129
IR and above (no ViV) aortic
French - Français,
Dutch - Nederlands,
German - Deutsch
No
N/A
2022-08-02
Edwards eSheath Introducer Set
149943003A_EC
9610ES14, 9610ES16, S3TF120, S3TF123, S3TF126, S3TF129
LR and above aortic, HR and above ViV, THV-in-THV/SV aortic, THV-in-SV mitral
English,
Spanish - Español,
Portuguese - Português
No
N/A
2020-08-24
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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