PMA P250019

Device: SAPIEN M3 Transcatheter Mitral Valve Replacement System
Applicant: Edwards Lifesciences, LLC
Product code: NPU
Decision date: 2026-04-16
Generic name: Prosthesis, mitral valve, percutaneously delivered
Approval order statement: an alternative method to process devices prior to RESILIA treatment, and cleanroom modifications to accommodate this alternative processing method

Current openFDA PMA Record#

Device: SAPIEN M3 Transcatheter Mitral Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P250019
Supplement: S003
Product code: NPU
Generic name: Prosthesis, mitral valve, percutaneously delivered
Decision date: 2026-04-16
Decision code: OK30
Date received: 2026-03-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative method to process devices prior to RESILIA treatment, and cleanroom modifications to accommodate this alternative processing method