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Alert System (Alert Catheter, Alert Interface Cable, and Alert Companion with Software Version 1.08)

by Dot Medical Products, Ltd. PMA

Withdrawn United States

PMA P990069

Overview

The Alert System is a temporary internal atrial defibrillation system designed for use in patients who are candidates for transvenous electrical cardioversion for the treatment of atrial fibrillation. It comprises an Alert catheter, Alert interface cable, and Alert companion device with software version 1.08, forming a complete system for acute internal atrial defibrillation.

Supplied by Dot Medical Products Ltd, the system is authorized under FDA PMA P990069 and classified as a Class III device. It is intended for use in clinical settings where transvenous electrical cardioversion is performed, with no indication of sterility, single-use status, MRI safety, or storage conditions provided in the data.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

Withdrawn since 27 Nov 2002. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP990069 Date27 Nov 2002Approval withdrawnStatusWithdrawn

Coverage

1 jurisdiction

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

United States — FDA PMA Withdrawn

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

Generic Name
System, pacing, temporary, acute, internal atrial defibrillation
FDA applicant
Dot Medical Products , Ltd.
PMA Number
FDA Product Code
MTE
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APWD Approval withdrawn

Questions

  • What is the Alert System indicated for?

    The Alert System is indicated for use in patients who are candidates for transvenous electrical cardioversion for the treatment of atrial fibrillation, as stated in the approval statement from the FDA PMA.

  • What components make up the Alert System?

    The Alert System consists of the Alert catheter, Alert interface cable, and Alert companion device with software version 1.08, as explicitly listed in the product name and trade name fields.

  • What regulatory authorization does the Alert System have?

    The Alert System has FDA PMA authorization under number P990069, as indicated in the AUTHORIZATIONS and pma_number fields of the device data.