Model 483-02 Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844269 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary purpose of the Model 483-02 Pacing Lead and how does it function in the body?

  The Model 483-02 Pacing Lead is designed to deliver controlled electrical impulses to the heart, helping regulate abnormal heart rhythms in patients with bradycardia or conduction disorders. It acts as a permanent pacemaker electrode, transmitting electrical stimulation directly to the heart tissue during surgical implantation to maintain proper cardiac function.

• Is the Model 483-02 Pacing Lead intended for reuse, or is it meant to be used only once?

  The Model 483-02 Pacing Lead is explicitly intended for single-use implantation only. This means it is not designed for repeated use and should be discarded after one surgical procedure to ensure patient safety and sterility.

• How is the Model 483-02 Pacing Lead supplied, and what precautions should be taken during handling?

  The Model 483-02 Pacing Lead is supplied sterile and requires surgical implantation. Since it is a sterile, single-use device, it must be handled with aseptic techniques to prevent contamination before and during the procedure. Always follow manufacturer guidelines for unpacking and preparation to maintain sterility.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Model 483-02 Pacing Lead was cleared through the FDA’s 510(k) pathway (K844269), specifically under a Traditional 510(k) review and classified as Substantially Equivalent (SESE) to a predicate device. This means it was determined to have the same intended use and technological characteristics as a previously cleared device, ensuring compliance with FDA standards for permanent pacemaker electrodes in cardiovascular applications.

• Are there different sizes or models of the Model 483-02 Pacing Lead, or is it a single standardized design?

  The provided data does not specify multiple sizes or models for the Model 483-02 Pacing Lead—it is described as a singular device intended for permanent pacemaker electrode implantation. However, the associated OpenFDA registration numbers suggest variations may exist in production batches or lot-specific details, though the core design remains consistent for its intended use.