PMA P230013S014
- Device
- EVOQUE Tricuspid Valve Replacement System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S014
- Product code
- NPW
- Decision date
- 2025-06-06
- Classification
- Cardiovascular
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Approval order statement
- changes to incoming receiving inspections for EVOQUE Tricuspid Valve Replacement System components
Current openFDA PMA Record#
- Device
- EVOQUE Tricuspid Valve Replacement System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S014
- Product code
- NPW
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Decision date
- 2025-06-06
- Decision code
- OK30
- Date received
- 2025-05-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to incoming receiving inspections for EVOQUE Tricuspid Valve Replacement System components