PMA P200015S076

Device: Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) System with Alterra Adaptive Prestent
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S076
Product code: NPV
Decision date: 2026-06-04
Classification: Cardiovascular
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: Approval for an update to the Magnetic Resonance (MR) Conditional statement in the labeling for the Edwards Alterra Adaptive Prestent.

Current openFDA PMA Record#

Device: Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) System with Alterra Adaptive Prestent
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S076
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2026-06-04
Decision code: APPR
Date received: 2026-03-09
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for an update to the Magnetic Resonance (MR) Conditional statement in the labeling for the Edwards Alterra Adaptive Prestent.