Paceart System

• • Terminated Z-0081-2008 FDA Unclassified (pre-2012) ·initiated 27 Aug 2007

  An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting

• • Terminated Z-0911-06 FDA Unclassified (pre-2012) ·initiated 2 Feb 2006

  The Paceart System could inappropriately insert data from a patient's Medtronic CareLink transmission into another patient's Paceart record. An issue associated with the automated batch transfer of implanted cardiac device data from the Medtronic CareLink network to the Paceart System exists.

1. 29 May 2003 Cleared FDA 510(k) K024278
2. 2 Feb 2006 Recall initiated FDA recalls Z-0911-06
3. 27 Aug 2007 Recall initiated FDA recalls Z-0081-2008

510(k) Number

K024278 ↗

FDA product code

DPS

Device class

Class II

Regulation

21 CFR Part 870.2340

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code DPS (Electrocardiograph).

• ELI 280 ELECTROCARDIOGRAPH by MORTARA INSTRUMENT, INC.
• ECG MODULE by Elscint, Inc.
• Electrocardiograph ECG301 by Shenzhen Le Medical Technology Co., Ltd.
• SCHILLER MINISCOPE MS-2 EKG SCOPE by Armstrong Ind., Inc.
• Welch Allyn, Inc. 901129 ELI150C-BDB-BDCBX by Welch Allyn, Inc.
• UNIVERSAL MEDDARS SYSTEM by Electronics For Medicine, Inc.
• MOBILE-PATIENT VIEWER by Data Critical Corp.
• EASY ECG PC BASED ELECTROCARDIOGRAPH by Ates Medical S.R.L.
• ELECTROCARDIOGRAPH by NIHON KOHDEN AMERICA, INC.
• Welch Allyn, Inc. 901133 ELI380-ACX12 by Welch Allyn, Inc.

• Pulse Generators

  Class III

  FDA 510(k) K772357 Active Cleared 17 Jan 1978

• Medtronic Pulse Generator

  Class III

  FDA 510(k) K811123 Active Cleared 27 May 1981

• Sutureless Myocardial Pacing Lead

  Class III

  FDA 510(k) K780446 Active Cleared 19 May 1978

• APTUS Heli-FX® HG-18-90-42

  Class II

  FDA 510(k) K140036 Active Cleared 6 Feb 2014 GUDID on market

See all devices from Medtronic Vascular, Inc. →