- Device
- Edwards EVOQUE Tricuspid Valve Replacement System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S021
- Product code
- NPW
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Decision date
- 2026-02-02
- Decision code
- OK30
- Date received
- 2026-01-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reducing the receiving inspection of components from a 100% Visual Inspection to a Lot Tolerance Percent Defective (LTPD) Inspection Sampling