HSA · registration DE0509711Medtronic Evolut™ FX System
- Registration number
- DE0509711
- Model name
- Evolut™ FX Delivery Catheter System; Evolut™ FX Delivery Catheter System; Evolut™ FX Transcatheter Aortic Valve; Evolut™ FX Transcatheter Aortic Valve; Evolut™ FX Transcatheter Aortic Valve; Evolut™ FX Transcatheter Aortic Valve; Evolut™ FX Loading System; Evolut™ FX Loading System
- Model identifier
- D-EVOLUTFX-2329; D-EVOLUTFX-34; EVOLUTFX-23; EVOLUTFX-26; EVOLUTFX-29; EVOLUTFX-34; L-EVOLUTFX-2329; L-EVOLUTFX-34
- Registration date
- September 02, 2024
- Risk class
- Class D
- Product owner
- Medtronic, Inc
- Registrant / registration holder
- MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
The Medtronic Evolut FX system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. The Medtronic Evolut FX system is also indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., STS predicted risk of operative mortality score ≥8% or at a ≥15% risk of mortality at 30 days).
- Product owner address
- 710 Medtronic Parkway, Minneapolis, MN 55432, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.