Edwards EVOQUE Tricuspid Valve Replacement System
FDA premarket approval P230013 · decided 2024-02-01
Approval details
- PMA number
- P230013
- Trade name
- Edwards EVOQUE Tricuspid Valve Replacement System
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2023-03-31
- Decision date
- 2024-02-01
- Days to decision
- 307 days
- Decision code
- APPR
- Product code
- NPW
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the Edwards EVOQUE Tricuspid Valve Replacement System. The device is indicated for the improvement of health status in patients with symptomatic severe tricuspid regurgitation (TR) despite optimal medical therapy (OMT), in whom tricuspid valve replacement is deemed appropriate by a heart team.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Respiration Rate algorithm (K251326) | Edwards Lifesciences, LLC | 2026-06-11 |
| HemoSphere Nano Monitor (HSNANO1) (K253186) | Edwards Lifesciences, LLC | 2026-02-24 |
| Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982) | Edwards Lifesciences, LLC | 2025-09-23 |
| Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688) | Edwards Lifesciences, LLC | 2025-09-17 |
| Hypertension Prediction Index (HePI) Algorithm (K242518) | Edwards Lifesciences, LLC | 2025-05-15 |
| FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (K242909) | Edwards Lifesciences, LLC | 2025-03-21 |
| Fogarty Thru-Lumen Embolectomy Catheter (K240078) | Edwards Lifesciences, LLC | 2024-08-28 |
| Acumen Assisted Fluid Management (AFM) Software Feature (K233984) | Edwards Lifesciences, LLC | 2024-08-02 |