Model 476-03 Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844260 ↗

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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See all devices from Intermedics, Inc. →

• What is the primary purpose of the Model 476-03 Pacing Lead, and where is it typically implanted in the body?

  The Model 476-03 Pacing Lead is designed to deliver electrical impulses to the heart, helping to treat cardiac rhythm disorders like bradycardia or conduction abnormalities. It is intended for single-use implantation within the cardiovascular system, specifically positioned in the right atrium or ventricle to interface with a pacemaker system and maintain regular heart rhythms.

• Is the Model 476-03 Pacing Lead meant for reuse, or is it intended for single-use only?

  The Model 476-03 Pacing Lead is explicitly designed for single-use implantation. It is supplied sterile and packaged for surgical use, ensuring it meets medical-grade standards for one-time use only.

• How is the Model 476-03 Pacing Lead classified under FDA regulations, and what type of clearance does it hold?

  The Model 476-03 Pacing Lead is classified as a Class III medical device under FDA regulation number 870.3680 and holds FDA 510(k) clearance through the Traditional pathway. This classification reflects its role in life-sustaining or supporting functions, requiring rigorous regulatory oversight.

• What type of advisory committee reviewed this device, and what was the outcome of that review?

  The Model 476-03 Pacing Lead was reviewed by the Cardiovascular (CV) Advisory Committee, and the FDA determined it to be substantially equivalent to a predicate device, as indicated by the decision code *SESE*. This outcome supports its classification and regulatory pathway.

• How should the Model 476-03 Pacing Lead be stored before use, given its sterile packaging?

  Since the Model 476-03 Pacing Lead is supplied sterile and packaged for surgical use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines to preserve sterility until implantation.