PMA P230013S005
- Device
- Edwards EVOQUE Tricuspid Valve Replacement System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S005
- Product code
- NPW
- Decision date
- 2024-05-23
- Classification
- Cardiovascular
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Approval order statement
- alternate chemical suppliers for bioprosthetic heart valve manufacturing
Current openFDA PMA Record#
- Device
- Edwards EVOQUE Tricuspid Valve Replacement System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S005
- Product code
- NPW
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Decision date
- 2024-05-23
- Decision code
- OK30
- Date received
- 2024-04-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- alternate chemical suppliers for bioprosthetic heart valve manufacturing