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Tendyne Transcatheter Mitral Valve System

FDA PMA

Class III (US FDA PMA)

PMA P240042

by Abbott Medical

Identity

Trade Name
Tendyne Transcatheter Mitral Valve System FDA PMA
Generic Name
Prosthesis, mitral valve, percutaneously delivered FDA PMA

Identifiers

PMA Number
P240042 FDA PMA
FDA Product Code
NPU FDA PMA

Classification

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

The Tendyne Transcatheter Mitral Valve System is a percutaneously delivered mitral valve prosthesis designed to replace a dysfunctional native mitral valve. It is intended for patients with symptomatic severe mitral valve dysfunction, including moderate-to-severe or severe mitral regurgitation, severe mitral stenosis, or moderate mitral regurgitation with moderate or greater mitral stenosis, in the presence of severe mitral annular calcification. This device is specifically intended for those deemed unsuitable for mitral valve surgery or transcatheter edge-to-edge repair by a multidisciplinary heart team.

The system is supplied as a transcatheter implant and is intended for single-use. It is delivered via a catheter-based approach, requiring fluoroscopic and echocardiographic guidance for proper positioning. The device is regulated under FDA Premarket Approval (PMA) and falls under Class III classification. Storage and handling must comply with sterile medical device protocols, as outlined in the manufacturer’s instructions.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Abbott Medical

Sources (1)

  • FDA PMA P240042 24 fields · synced Sep 18, 2026