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Precise Nitinol Stent System

by Cordis US Corporation

PMA P030047

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P030047↗

FDA record

Trust

Unverified

Source FDA PMA, synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP030047 Date22 Sep 2006ApprovedStatusActive

Official records

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-0729-2020 FDA Class II initiated 14 Nov 2019

    Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".

    • Completed Z-1257-2021 FDA Class I initiated 11 Feb 2021

    Distal tip may become separated from the lumen wire in specific lots.

  • 2 recalls, same reason

    • Terminated Z-1946-2016 FDA Class II initiated 4 May 2016
    • Terminated Z-1947-2016 FDA Class II initiated 4 May 2016

    Inability to deploy the stent or partial stent deployment.

Timeline

5 dated events

  1. Approved FDA PMA P030047
  2. Recall initiated FDA recalls Z-1946-2016
  3. Recall initiated FDA recalls Z-1947-2016
  4. Recall initiated FDA recalls Z-0729-2020
  5. Recall initiated FDA recalls Z-1257-2021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Full name
Precise Nitinol Stent System/Precise Rx Nitinol Stent System/Precise Pro Rx Nitinol Stent System
Trade name
Cordis Precise Nitinol Stent System
Generic name
Stent, carotid
PMA number
FDA product code
NIM
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 Precise Nitinol Stent System is a carotid stent designed for the treatment of patients who require carotid revascularization. It is indicated for use in conjunction with the AngioGuard XP emboli capture guidewire for patients at high risk for adverse events from carotid endarterectomy.

This device is intended for patients with specific stenosis criteria in the common or internal carotid artery and requires a vessel diameter of 4-9mm at the target lesion. The system is available in 5.5 Fr and 6.0 Fr sizes in an over-the-wire configuration. It has received FDA PMA approval for clinical use.

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