Edwards EVOQUE Tricuspid Valve Replacement System
FDA premarket approval P230013/S010 · decided 2025-02-11
Approval details
- PMA number
- P230013
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Edwards EVOQUE Tricuspid Valve Replacement System
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2024-11-14
- Decision date
- 2025-02-11
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- NPW
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for a new model of the loading system (Model 9850LSB) that incorporates minor changes in design and materials and an update to the Instructions for Use to include the option of hospital staff to participate in valve loading
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510(k) clearances by this applicant
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|---|---|---|
| Respiration Rate algorithm (K251326) | Edwards Lifesciences, LLC | 2026-06-11 |
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| Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688) | Edwards Lifesciences, LLC | 2025-09-17 |
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| 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 |