PMA P230013S006

Device: EVOQUE Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S006
Product code: NPW
Decision date: 2024-07-30
Classification: Cardiovascular
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Approval order statement: the addition of a new ethylene oxide (EO) sterilization cycle to reduce the EO gas concentration

Current openFDA PMA Record#

Device: EVOQUE Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S006
Product code: NPW
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Decision date: 2024-07-30
Decision code: OK30
Date received: 2024-07-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of a new ethylene oxide (EO) sterilization cycle to reduce the EO gas concentration