Edwards SAPIEN M3 Transcatheter Heart Valve - 26mm

FDA PMA

Class III (US FDA PMA)

PMA P250019

by Edwards Lifesciences LLC

Identity

Trade Name: SAPIEN M3 Transcatheter Mitral Valve Replacement System FDA PMA
Generic Name: Prosthesis, mitral valve, percutaneously delivered FDA PMA

Identifiers

PMA Number: P250019 FDA PMA
FDA Product Code: NPU FDA PMA
Models / Variants: sizes 20mm FDA PMA
23mm FDA PMA
26mm FDA PMA
29mm FDA PMA

Classification

Device Class: Class III FDA PMA
Advisory Committee: Cardiovascular FDA PMA
FDA Decision: APPR Approved FDA PMA

The SAPIEN M3 Transcatheter Heart Valve is a percutaneously delivered mitral valve prosthesis designed for transcatheter mitral valve replacement. It is classified as a Class III device under FDA regulations and intended for use in patients with symptomatic moderate-to-severe or severe mitral regurgitation or mitral stenosis, including those with mitral annular calcification.

This device is supplied in four sizes (20mm, 23mm, 26mm, 29mm) and is intended for use in patients deemed unsuitable for surgery or transcatheter edge-to-edge repair (TEER) by a multidisciplinary heart team. The SAPIEN M3 system received FDA_PMA approval under PMA number P250019, with the authorization explicitly stating its use for transcatheter mitral valve replacement. No additional regulatory status or sterility claims are provided in the specifications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Edwards Lifesciences – the leading global structural heart innovation ..., Edwards Lifesciences – the leading global structural heart innovation ..., Edwards Lifesciences – Wikipedia, Edwards Lifesciences - Wikipedia, Edwards Lifesciences - Herzmedizin.de

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	United States	FDA_PMA	P250019	Class III	Active

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Manufacturer

Manufacturer: Edwards Lifesciences LLC
FDA Applicant: Edwards Lifesciences, LLC

Sources (1)

FDA PMA P250019 24 fields · synced Sep 18, 2026