PMA P230013S028
- Device
- Edwards EVOQUE Loading System and Trimmer, Model 9850LSB
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S028
- Product code
- NPW
- Decision date
- 2026-04-29
- Classification
- Cardiovascular
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Approval order statement
- modifications to a component of the loading system and removal of a non-critical inspection
Current openFDA PMA Record#
- Device
- Edwards EVOQUE Loading System and Trimmer, Model 9850LSB
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P230013
- Supplement
- S028
- Product code
- NPW
- Generic name
- Percutaneously Delivered Prostheses and Tricuspid Valves
- Decision date
- 2026-04-29
- Decision code
- OK30
- Date received
- 2026-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- modifications to a component of the loading system and removal of a non-critical inspection