PMA P230013S009
- Device
- Edwards EVOQUE Tricuspid Valve Replacement System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S009
- Product code
- NPW
- Decision date
- 2024-08-30
- Classification
- Cardiovascular
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Approval order statement
- an alternative in-house supplier for the lumen subassemblies of the EVOQUE delivery system
Current openFDA PMA Record#
- Device
- Edwards EVOQUE Tricuspid Valve Replacement System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S009
- Product code
- NPW
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Decision date
- 2024-08-30
- Decision code
- OK30
- Date received
- 2024-08-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternative in-house supplier for the lumen subassemblies of the EVOQUE delivery system