PMA P230013S033
- Device
- EVOQUE Tricuspid Valve Replacement System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S033
- Product code
- NPW
- Decision date
- 2026-10-21
- Classification
- Cardiovascular
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Approval order statement
- Approval for design changes to the guide pin components used in the delivery system
Current openFDA PMA Record#
- Device
- EVOQUE Tricuspid Valve Replacement System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S033
- Product code
- NPW
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Decision date
- 2026-10-21
- Decision code
- APPR
- Date received
- 2026-07-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design changes to the guide pin components used in the delivery system