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PALMAZ MULLINS XD Pulmonary Stent

by Cordis US Corp.

PMA P220004

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P220004↗

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 NumberP220004 Date21 Jul 2023ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Pulmonary stent
FDA applicant
Cordis US Corp
PMA Number
FDA Product Code
QWC
Device Class
Class III
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 Palmaz Mullins XD Pulmonary Stent is a Class III medical device classified as a pulmonary stent, designed for the non-emergency treatment of pulmonary artery stenosis in pediatric patients weighing at least 10 kg with two-ventricle anatomy. Constructed as a stainless-steel mesh tube, it is intended to mechanically widen narrowed pulmonary arteries to restore blood flow.

This device is supplied in a sterile, gamma-irradiated form and is intended for single-use. It is regulated under an FDA Premarket Approval (PMA) application (P220004) and is restricted to sale by or on the order of a physician. The stent’s design emphasizes flexibility and adaptability for smooth navigation through complex vascular anatomy, with specifications tailored for pediatric use.

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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 Palmaz Mullins XD Pulmonary Stent specifically designed to treat, and who is it intended for?

    The Palmaz Mullins XD Pulmonary Stent is designed to treat **pulmonary artery stenosis** in pediatric patients who weigh at least **10 kg** and have a **two-ventricle anatomy**. It is not intended for emergency use and is tailored for non-emergency mechanical widening of narrowed pulmonary arteries to restore blood flow.

  • Is this device reusable, or is it meant for single-use only? How is it sterilized?

    The Palmaz Mullins XD Pulmonary Stent is **intended for single-use only**. It is supplied in a **sterile, gamma-irradiated** form to ensure safety and efficacy for one-time clinical application.

  • How is this stent different from other pulmonary stents in terms of its design and flexibility?

    This stent features a **stainless-steel mesh tube** with a design optimized for **flexibility and adaptability**, allowing it to navigate complex pediatric vascular anatomy smoothly. Its specifications are explicitly tailored for **pediatric use**, distinguishing it from adult-sized pulmonary stents.

  • Who can purchase or prescribe this device, and what regulatory approval does it hold?

    The Palmaz Mullins XD Pulmonary Stent is **restricted to sale by or on the order of a physician** only. It holds **FDA Premarket Approval (PMA)** under application number **P220004**, confirming its compliance with stringent regulatory standards for Class III devices.