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Harmony Transcatheter Pulmonary Valve System

by Medtronic, Inc.

PMA P200046

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

PMA P200046↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP200046 Date26 Mar 2021ApprovedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2624-2026 FDA Class I initiated 22 May 2026

    Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.

    • Ongoing Z-0927-2022 FDA Class I initiated 2 Mar 2022

    There is potential for the capsule bond to break during the procedure.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Harmony TPV System
Generic name
Pulmonary valve prosthesis percutaneously delivered
PMA number
FDA product code
NPV
Device class
Unclassified
Advisory committee
Cardiovascular
FDA decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Harmony Transcatheter Pulmonary Valve System is a percutaneous pulmonary valve prosthesis designed for transcatheter implantation. It is intended for patients with severe pulmonary regurgitation, including those with a native or surgically repaired right ventricular outflow tract who require surgical pulmonary valve replacement.

This device is supplied sterile and intended for single-use. It is delivered via catheter-based techniques and is approved for use in pediatric and adult patients. The system is regulated under FDA PMA (Premarket Approval) and falls under the NPV product code for pulmonary valve prostheses. No MRI safety information is specified in the data.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Harmony TPV System used for in clinical practice, and who are the intended patients?

    The Harmony TPV System is a percutaneous pulmonary valve prosthesis designed for patients with severe pulmonary regurgitation, specifically those who have a native or surgically repaired right ventricular outflow tract and require surgical pulmonary valve replacement. It is approved for use in both pediatric and adult patients, as determined by echocardiography or cardiac MRI showing a pulmonary regurgitant fraction of 30% or higher.

  • Is the Harmony TPV System intended for single-use or repeat use, and how is it supplied?

    The Harmony TPV System is supplied sterile and intended for single-use only. It is delivered via catheter-based techniques, meaning it is implanted through a minimally invasive procedure without the need for open surgery.

  • What regulatory pathway does the Harmony TPV System follow, and how does this affect its availability?

    The Harmony TPV System follows the FDA Premarket Approval (PMA) pathway, indicated by the PMA number P200046. This approval confirms its safety and effectiveness for the specified use in managing severe pulmonary regurgitation in eligible patients. Availability is governed by this regulatory clearance.

  • Can the Harmony TPV System be used in patients who have had prior surgical interventions on their right ventricular outflow tract?

    Yes, the Harmony TPV System is explicitly designed for patients with a native or surgically repaired right ventricular outflow tract. This includes those who have undergone prior surgical interventions requiring pulmonary valve replacement, as long as they meet the criteria for severe pulmonary regurgitation.

  • Are there any specific MRI safety considerations mentioned for the Harmony TPV System?

    The provided data does not specify any MRI safety information for the Harmony TPV System. Clinicians should consult the device labeling or manufacturer guidance for MRI-related precautions before exposing patients to MRI environments.