Edwards EVOQUE Tricuspid Valve Replacement System
FDA premarket approval P230013/S004 · decided 2024-10-03
Approval details
- PMA number
- P230013
- Supplement
- S004
- 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
- 2024-04-25
- Decision date
- 2024-10-03
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- NPW
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for (1) addition of the 56 mm valve size; (2) various minor material and manufacturing changes to all valve sizes, including changing the anchor padding material and laser-cutting of the cloth components; and (3) various design changes to the EVOQUE loading system (Model 9850LSA).
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