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Scoreflex NC Scoring PTCA Catheter

by OrbusNeich Medical (Shenzhen) Co., Ltd.

PMA P200041

Active European Union and United States

CE MDD PMA

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P200041↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP200041 Date21 Dec 2021ApprovedStatusActive
European UnionCE/MDD Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA PMA Active

Specification

PMA

Full name
Scoreflex NC
Trade Name
Scoreflex NC Scoring PTCA Catheter
Generic Name
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
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 Scoreflex NC Scoring PTCA Catheter is a percutaneous transluminal coronary angioplasty (PTCA) catheter with cutting/scoring functionality. It is designed for balloon dilatation of a de novo stenotic portion of a coronary artery and in-stent restenosis in coronary arteries. The device is intended to improve myocardial perfusion in patients evidencing coronary ischemia. The Scoreflex NC Scoring PTCA Catheter is classified as a Class 3 device.

The Scoreflex NC Scoring PTCA Catheter is supplied by OrbusNeich Medical (Shenzhen) Co., Ltd. and has received FDA PMA approval. The device has a product code of NWX and is registered with the FDA. The catheter is indicated for use in coronary arteries and is designed to be used in a clinical setting.

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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 intended use of the Scoreflex NC Scoring PTCA Catheter?

    The Scoreflex NC Scoring PTCA Catheter is intended for balloon dilatation of a de novo stenotic portion of a coronary artery and in-stent restenosis in coronary arteries in patients evidencing coronary ischemia, for the purpose of improving myocardial perfusion.

  • What type of device is the Scoreflex NC Scoring PTCA Catheter?

    The Scoreflex NC Scoring PTCA Catheter is a percutaneous transluminal coronary angioplasty (PTCA) catheter with cutting/scoring functionality, classified as a Class 3 device.

  • Has the Scoreflex NC Scoring PTCA Catheter received FDA approval?

    Yes, the Scoreflex NC Scoring PTCA Catheter has received FDA PMA approval, with a PMA number of P200041.