Evolut PRO+ System, Evolut FX System, Evolut FX+ System
FDA premarket approval P130021/S174 · decided 2025-08-27
Approval details
- PMA number
- P130021
- Supplement
- S174
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Evolut PRO+ System, Evolut FX System, Evolut FX+ System
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Medtronic, Inc.
- Date received
- 2025-02-28
- Decision date
- 2025-08-27
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miinneapolis, MN
- Statement
- Approval for the Evolut PRO+ System, Evolut FX System, Evolut FX+ System for expanding the indications to include the treatment of patients with a failed trascatheter aortic valve who are at high or greater risk of mortality from open surgical therapy. This device is indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon,
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |