PMA P230013S031
- Device
- EVOQUE Tricuspid Delivery System (9850TDS); EVOQUE dilator kit (9850DK)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S031
- Product code
- NPW
- Decision date
- 2026-07-29
- Classification
- Cardiovascular
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Approval order statement
- automation of a component cleaning process
Current openFDA PMA Record#
- Device
- EVOQUE Tricuspid Delivery System (9850TDS); EVOQUE dilator kit (9850DK)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S031
- Product code
- NPW
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Decision date
- 2026-07-29
- Decision code
- OK30
- Date received
- 2026-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- automation of a component cleaning process