- Device
- EVOQUE Transcatheter Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S001
- Product code
- NPW
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Decision date
- 2024-03-15
- Decision code
- APPR
- Date received
- 2024-02-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at 12050 Lone Peak Parkway, Draper, UT 84020 as an alternative finished goods manufacturing site for the EVOQUE transcatheter tricuspid delivery system, EVOQUE dilator kit, and EVOQUE loading System