PMA P230013S022

Device: Edwards EVOQUE Loading System (9850LSA); Edwards EVOQUE Loading System and Trimmer (9850LSB)
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S022
Product code: NPW
Decision date: 2026-02-11
Classification: Cardiovascular
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Approval order statement: adoption of Edwards EVOQUE Loading Systems and Trimmer to an already validated EO sterilization cycle

Current openFDA PMA Record#

Device: Edwards EVOQUE Loading System (9850LSA); Edwards EVOQUE Loading System and Trimmer (9850LSB)
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S022
Product code: NPW
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Decision date: 2026-02-11
Decision code: OK30
Date received: 2026-01-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: adoption of Edwards EVOQUE Loading Systems and Trimmer to an already validated EO sterilization cycle