PMA P200015

Device: Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S032
Product code: NPV
Decision date: 2026-04-09
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: Approval for updates to the Instructions for Use and Patient Implant Cards related to magnetic resonance imaging safety information (P200015 and P140031) and sizing recommendations for valve-in-valve implantation in a failing INSPIRIS RESILIA aortic valve (P140031 only).

Current openFDA PMA Record#

Device: Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S072
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2026-04-09
Decision code: APPR
Date received: 2026-01-09
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for updates to the Instructions for Use and Patient Implant Cards related to magnetic resonance imaging safety information (P200015 and P140031) and sizing recommendations for valve-in-valve implantation in a failing INSPIRIS RESILIA aortic valve (P140031 only).