PMA P140031S088

Device: SAPIEN 3 Ultra Transcatheter Heart Valve System
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S088
Product code: NPT
Decision date: 2019-06-04
Classification: Aortic Valve, Prosthesis, Percutaneously Delivered
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: Approval for updates to the labeling of the SAPIEN 3 Ultra Transcatheter Heart Valve and Accessories regarding the option to use the eSheath as an accessory for the SAPIEN 3 Ultra procedure.

Current openFDA PMA Record#

Device: SAPIEN 3 Ultra Transcatheter Heart Valve System
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S088
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2019-06-04
Decision code: APPR
Date received: 2019-05-28
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for updates to the labeling of the SAPIEN 3 Ultra Transcatheter Heart Valve and Accessories regarding the option to use the eSheath as an accessory for the SAPIEN 3 Ultra procedure.