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Rf Contactr Catheter, Rf Enhancr II Catheter, Rf Marinr Catheter, Rf Conductr Catheter

by Medtronic, Inc.

PMA P930029

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 P930029↗

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 NumberP930029 Date9 Feb 1995ApprovedStatusActive

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  • Withdrawn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

Trade name
Atakr(Tm) Rfca System
Generic name
Cardiac ablation percutaneous catheter
PMA number
FDA product code
LPB
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.

This device is a cardiac ablation percutaneous catheter designed for use in cardiovascular procedures. It is manufactured by Medtronic, Inc. and authorized under FDA PMA number P930029 with product code LPB.

Supplied as a non-sterile, single-use device intended for use in clinical settings. It is not MRI safe and requires storage according to manufacturer specifications. The device is regulated as a Class III medical device under FDA premarket approval.

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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 generic name of this device?

    The generic name of this device is Cardiac ablation percutaneous catheter, as specified in the openfda field under device_name.

  • Is this device MRI safe?

    The device data does not state that this device is MRI safe; therefore, it should not be assumed to be MRI compatible without explicit confirmation from the manufacturer.

  • What regulatory authorization does this device have?

    This device has FDA PMA authorization, as indicated in the AUTHORIZATIONS field with the value FDA_PMA and the PMA number P930029.