PMA P200015S068

Device: Edwards SAPIEN 3 Transcatheter Pulmonic Valve Delivery System
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S068
Product code: NPV
Decision date: 2026-01-28
Classification: Cardiovascular
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: Approval for the next generation SAPIEN 3 pulmonic delivery system (models 9631PL20, 9631PL23, 9631PL26, and 9631PL29) and various updates to the Magnetic Resonance (MR) Safety information in the device labeling.

Current openFDA PMA Record#

Device: Edwards SAPIEN 3 Transcatheter Pulmonic Valve Delivery System
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S068
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2026-01-28
Decision code: APPR
Date received: 2025-08-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the next generation SAPIEN 3 pulmonic delivery system (models 9631PL20, 9631PL23, 9631PL26, and 9631PL29) and various updates to the Magnetic Resonance (MR) Safety information in the device labeling.