PMA P140031S196

Device: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm) 9750TFX; Edwards SAPIEN 3 Ultra RESILIA Transc
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S196
Product code: NPT
Decision date: 2025-12-17
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: to implement a new sewing method for the attachment of the Main and paravalvular Skirts to the valve frame in certain valve models/sizes

Current openFDA PMA Record#

Device: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm) 9750TFX; Edwards SAPIEN 3 Ultra RESILIA Transc
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S196
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2025-12-17
Decision code: OK30
Date received: 2025-11-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to implement a new sewing method for the attachment of the Main and paravalvular Skirts to the valve frame in certain valve models/sizes