PMA P140031S197

Device: Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, Models 9755RSL20, 9755RSL23, 9755RSL26, and 9755RSL29
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S197
Product code: NPT
Decision date: 2025-12-17
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, percutaneously delivered
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 SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, Models 9755RSL20, 9755RSL23, 9755RSL26, and 9755RSL29
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S197
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
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