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Guardian ATP II Implantable Cardioverter Defibrillator System

by Telectronics Pacing Systems, Inc.

PMA P940024

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 P940024↗

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 NumberP940024 Date3 Jul 1997ApprovedStatusActive

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  • Withdrawn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

Full name
Guardian(R) Atp II Implantable Cardioverter/Difib.
Generic Name
Implantable cardioverter defibrillator (non-CRT)
PMA Number
FDA Product Code
LWS
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 Guardian ATP II Implantable Cardioverter Defibrillator System is a Class III medical device classified as an Implantable Cardioverter Defibrillator (Non-CRT). It is designed to monitor and treat life-threatening ventricular arrhythmias, including ventricular fibrillation and sustained ventricular tachycardia, in patients at high risk of sudden cardiac death. The system delivers anti-tachycardia pacing (ATP) and defibrillation therapy to restore normal heart rhythm when abnormal rhythms are detected.

The system comprises the Guardian ATP II Model 4211 Implantable Cardioverter Defibrillator, compatible patch leads (Models 040-105, 040-106, 040-107, 040-128, 040-129, and 040-130), an implant support device (Model 4510), a generic personality module, and associated accessories. Supplied sterile and intended for single-use implantation, the device requires surgical placement under sterile conditions. Authorized under FDA Premarket Approval (PMA P940024), it is regulated as a high-risk device under the LWS product code.

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