PMA P140031S201

Device: Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, SAPIEN 3 Ultra Transcatheter Heart Valve System
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S201
Product code: NPT
Decision date: 2026-04-16
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, 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: Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, SAPIEN 3 Ultra Transcatheter Heart Valve System
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S201
Product code: NPT
Generic name: Aortic valve, prosthesis, 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