Approvals/TGA/Evolut™ FX+ System - Aortic transcatheter heart valve bioprosthesis, stent-like framework

Approved

STANDARD

Evolut™ FX+ System - Aortic transcatheter heart valve bioprosthesis, stent-like framework

Medtronic Australasia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: fd2eec203e20f68a
Product Name: Evolut™ FX+ System - Aortic transcatheter heart valve bioprosthesis, stent-like framework
Artg Id: 503429
Artg Name: Medtronic Australasia Pty Ltd - Evolut™ FX+ System - Aortic transcatheter heart valve bioprosthesis, stent-like framework
Sponsor: Medtronic Australasia Pty Ltd
Company Detail Path: /organization/medtronic-australasia-pty-ltd
Artg Date: 2025-07-21
Registration Type: Device
Therapeutic Good Type: Medical device
Licence Status: A
Licence Category: INC

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

fd2eec203e20f68a

Type

Standard