Model 483-01 Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844267 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K813518 Active Cleared 12 Jan 1982

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  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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See all devices from Intermedics, Inc. →

• What is the primary purpose of the Model 483-01 Pacing Lead, and where is it typically implanted in the body?

  The Model 483-01 Pacing Lead is designed to deliver electrical impulses to the heart, specifically for treating bradycardia or other cardiac conduction disorders. It is intended for implantation within the cardiovascular system, where it is typically positioned in either the right atrium or the right ventricle to stimulate cardiac contractions and maintain proper heart rhythm.

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

  The Model 483-01 Pacing Lead is supplied sterile and intended for single-use only. To maintain sterility and ensure safe use, it must be stored according to the manufacturer’s instructions, which likely include keeping it in its original packaging and protecting it from contamination until implantation.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?

  The Model 483-01 Pacing Lead received FDA clearance through a 510(k) submission (K844267) under the Traditional Review pathway, determined to be *substantially equivalent* to a predicate device. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device under 21 CFR 870.3680.

• Does this device require any special handling or preparation before use, beyond standard sterile procedures?

  Beyond standard sterile handling, the Model 483-01 Pacing Lead must be used in accordance with the manufacturer’s instructions to ensure proper implantation and functionality. Since it is intended for permanent use, adherence to sterile techniques during surgery and careful adherence to the provided guidelines are critical to avoid complications or device failure.