Model 483-01 Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844262 ↗

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 483-01 Pacing Lead, and how does it function in the body?

  The Model 483-01 Pacing Lead is designed as a permanent pacemaker electrode to transmit electrical impulses from an implanted pacemaker to the heart muscle. Its function is to stimulate the heart’s electrical activity when the patient’s natural rhythm is irregular or insufficient, helping to maintain a normal heart rhythm.

• Is the Model 483-01 Pacing Lead intended for single-use or reusable applications, and how is it supplied?

  The Model 483-01 Pacing Lead is intended for single-use implantation only and is supplied sterile, ensuring it meets clinical standards for sterile surgical procedures.

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

  The Model 483-01 Pacing Lead received FDA 510(k) clearance under the traditional review process, with a decision of *Substantially Equivalent* to a predicate device. This means it was determined to have the same intended use and technological characteristics as an already-approved pacemaker lead, ensuring compliance with FDA regulations for permanent pacemaker electrodes (regulation number 870.3680).

• What types of patients is this pacing lead intended for, and what clinical need does it address?

  This lead is intended for patients requiring cardiac pacing due to conditions causing abnormal heart rhythms, such as bradycardia or heart block. It is specifically designed to provide electrical stimulation to the heart muscle when the patient’s natural conduction system is insufficient, helping restore and maintain a regular heartbeat.

• How is the Model 483-01 Pacing Lead categorized in terms of medical specialty and regulatory classification?

  The lead falls under the cardiovascular medical specialty and is classified as a Class III medical device under FDA regulations. It adheres to the DTB product code (for pacemaker leads) and is regulated under 21 CFR 870.3680, which governs permanent pacemaker electrodes.