Evolut FX+ TAV, Evolut FX DCS, Evolut FX LS
FDA premarket approval P130021/S155 · decided 2024-03-22
Approval details
- PMA number
- P130021
- Supplement
- S155
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Evolut FX+ TAV, Evolut FX DCS, Evolut FX LS
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Medtronic, Inc.
- Date received
- 2024-01-26
- Decision date
- 2024-03-22
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miinneapolis, MN
- Statement
- Approval for design and manufacturing modifications to the Evolut FX System to incorporate larger openings in the stent frame. The device, as modified, will be marketed under the trade name Evolut FX+ System.
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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 |