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Establishment Registration & Device Listing

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6 to 10 of 23 Results for Product Code : NPT

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Establishment
Name

Registration Number

Current
Registration Yr

Edwards Lifesciences Ireland Limited

IRELAND

3017298588

2026

aortic valve, prosthesis, percutaneously delivered - Edwards Certitude Delivery System; Edwards Certitude Introducer Sheath; Edwards Certitude Introducer Sheath Set; Edwards Commander Delivery System; Edwards Crimper; Edwards eSheath Introducer Set- 914ES; Edwards eSheath Introducer Set- 916ES; Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; eSheath- 914ES; eSheath- 916ES

Manufacturer

EDWARDS LIFESCIENCES LLC

CA/USA

2015691

2026

aortic valve, prosthesis, percutaneously delivered - Edwards Certitude Delivery System; Edwards Certitude Introducer Sheath; Edwards Certitude Introducer Sheath Set; Edwards Commander Delivery System; Edwards Crimper; Edwards eSheath Introducer Set- 914ES; Edwards eSheath Introducer Set- 916ES; Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; eSheath- 914ES; eSheath- 916ES

Manufacturer; Specification Developer

aortic valve, prosthesis, percutaneously delivered - Ascendra + Introducer Sheath Set; Ascendra+ Delivery System; Ascendra+ System; Crimp Stopper; Edwards Crimper; Edwards Dilator Kit; Edwards Expandable Introducer Sheath Set; Edwards SAPIEN XT Transcatheter Heart Valve; NovaFlex + Delivery System; NovaFlex+ System; Qualcrimp crimping accessory

Manufacturer

Edwards Lifesciences LLC

UT/USA

3008500478

2026

aortic valve, prosthesis, percutaneously delivered - Ascendra + Introducer Sheath Set; Ascendra+ Delivery System; Ascendra+ System; Crimp Stopper; Edwards Crimper; Edwards Dilator Kit; Edwards Expandable Introducer Sheath Set; Edwards SAPIEN XT Transcatheter Heart Valve; NovaFlex + Delivery System; NovaFlex+ System; Qualcrimp crimping accessory

Manufacturer

aortic valve, prosthesis, percutaneously delivered - Edwards Certitude Delivery System; Edwards Certitude Introducer Sheath; Edwards Certitude Introducer Sheath Set; Edwards Commander Delivery System; Edwards Crimper; Edwards eSheath Introducer Set- 914ES; Edwards eSheath Introducer Set- 916ES; Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; eSheath- 914ES; eSheath- 916ES

Manufacturer

JenaValve Production Limited

UNITED KINGDOM

3011894841

2026

aortic valve, prosthesis, percutaneously delivered - JenaValve; JenaValve Trilogy Transcatheter Heart Valve System

Manufacturer

aortic valve, prosthesis, percutaneously delivered - JenaValve Trilogy Transcatheter Heart Valve System; Trilogy Delivery Catheter; Trilogy Introducer Sheath; Trilogy Loading Tools; Trilogy Transcatheter Heart Valve (THV)

Manufacturer

JENAVALVE TECHNOLOGY, INC.

CA/USA

3012148004

2026

aortic valve, prosthesis, percutaneously delivered - JenaValve Trilogy Transcatheter Heart Valve System; Trilogy Delivery Catheter; Trilogy Introducer Sheath; Trilogy Loading Tools; Trilogy Transcatheter Heart Valve (THV)

Manufacturer; Specification Developer

aortic valve, prosthesis, percutaneously delivered - JenaValve; JenaValve Trilogy Transcatheter Heart Valve System

Manufacturer; Specification Developer; Complaint File Establishment

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