TRIFORMIS RESILIA Tricuspid Valve
FDA premarket approval P150048/S092 · decided 2025-10-27
Approval details
- PMA number
- P150048
- Supplement
- S092
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TRIFORMIS RESILIA Tricuspid Valve
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2025-04-30
- Decision date
- 2025-10-27
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the MITRIS RESILIA Mitral Valve for expanding the indications to include the tricuspid position. The device, as modified, will be marketed under the trade name TRIFORMIS RESILIA Tricuspid Valve and is indicated for the replacement of native or prosthetic tricuspid heart valves.
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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 |