Model 479-01 Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844271 ↗

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 479-01 Pacing Lead, and how does it function in the body?

  The Model 479-01 Pacing Lead is designed to deliver electrical impulses to the heart to treat bradycardia or other cardiac conduction disorders. It functions by being implanted within the heart’s chambers, where it stimulates contractions when the natural pacemaker fails to maintain an adequate heart rhythm. This ensures consistent and regulated heartbeats, improving overall cardiac function.

• Is the Model 479-01 Pacing Lead intended for reuse, or is it meant for single-use only?

  The Model 479-01 Pacing Lead is explicitly intended for single-use implantation in a clinical setting, such as an operating room or cardiac catheterization lab. It is supplied sterile and must be handled with aseptic technique, meaning it should not be reused after initial implantation to prevent infection or compromise of device integrity.

• What storage conditions should be followed for the Model 479-01 Pacing Lead before use?

  While the provided data does not specify exact storage conditions, the lead is supplied sterile and intended for surgical implantation. Standard practices for sterile medical devices apply, including protection from contamination, extreme temperatures, and physical damage. Always follow manufacturer guidelines for unpacking and preparing the device prior to use in a sterile field.

• Can this pacing lead be used in patients who require MRI scans, or is it MRI-compatible?

  The Model 479-01 Pacing Lead is not MRI-compatible. This means it should not be used in patients who require magnetic resonance imaging (MRI) scans, as the magnetic fields could potentially interfere with the device’s function or cause harm. Always verify compatibility with the patient’s treatment plan before implantation.

• How was the regulatory approval process for this device determined, and what type of clearance did it receive?

  The Model 479-01 Pacing Lead received FDA 510(k) clearance under the Traditional review pathway, determined to be substantially equivalent to a predicate device. The decision was made by the Cardiovascular (CV) Advisory Committee, and the device is classified as a Class III medical device under FDA regulations (21 CFR 870.3680), reflecting its critical role in treating life-threatening cardiac conditions.