PMA P150048S095

Device: Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, Sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm; Edwards KONECT RESILI
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S095
Product code: LWR
Decision date: 2025-12-17
Classification: Cardiovascular
Generic name: heart-valve, non-allograft tissue
Approval order statement: to implement an alternative GLX Universal Fixture Assembly used in the GLX Semi-Automation machine for the GLX tissue treatment process

Current openFDA PMA Record#

Device: Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, Sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm; Edwards KONECT RESILI
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S095
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2025-12-17
Decision code: OK30
Date received: 2025-11-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to implement an alternative GLX Universal Fixture Assembly used in the GLX Semi-Automation machine for the GLX tissue treatment process