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Lacrosse NSE ALPHA Coronary Dilatation Catheter

by Goodman Co., Ltd.

PMA P230026

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 P230026↗

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 NumberP230026 Date6 Jun 2024ApprovedStatusActive

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  • Withdrawn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
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
FDA applicant
NIPRO VASCULAR CORPORATION (formerly Goodman Co., Ltd.)
PMA Number
FDA Product Code
NWX
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 Lacrosse NSE Alpha Coronary Dilatation Catheter is a percutaneous transluminal coronary angioplasty (PTCA) cutting and scoring catheter. It is indicated for balloon dilatation of stenotic portions of the coronary artery, including both de novo lesions and in-stent restenosis, to improve myocardial perfusion.

This device is manufactured by Goodman Co., Ltd. and has received FDA PMA authorization. It is designed for use in cardiovascular procedures to address arterial narrowing through controlled dilatation.

Other devices from Goodman Co., Ltd.

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 primary function of the Lacrosse NSE Alpha Coronary Dilatation Catheter?

    This device is a cutting and scoring PTCA catheter used for balloon dilatation of stenotic coronary arteries, which helps to improve blood flow to the heart muscle.

  • What types of lesions can this catheter treat?

    The catheter is indicated for the treatment of both de novo coronary artery lesions and in-stent restenosis.

  • Is the Lacrosse NSE Alpha Coronary Dilatation Catheter FDA authorized?

    Yes, the device has received FDA PMA authorization, as indicated by the regulatory data provided for this product.