Model 483-03 Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844268 ↗

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) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary purpose of the Model 483-03 Pacing Lead, and how does it function in the body?

  The Model 483-03 Pacing Lead is designed to deliver electrical stimulation to the heart muscle (myocardium) during implantation in the cardiovascular system. It facilitates cardiac pacing by transmitting pacing pulses, helping maintain a proper heart rhythm in patients with bradycardia (slow heart rate) or conduction disorders. Essentially, it acts as an electrode to ensure the heart beats consistently when natural electrical signals are insufficient.

• Is the Model 483-03 Pacing Lead intended for reuse, or is it meant for single-use only?

  The Model 483-03 Pacing Lead is explicitly supplied sterile and intended for single-use implantation within the body. This design ensures patient safety by preventing cross-contamination and maintaining device integrity for one-time use only.

• How should the Model 483-03 Pacing Lead be stored to preserve its sterility and functionality?

  The lead must be stored according to the manufacturer’s instructions to maintain both sterility and functionality. Since it is supplied sterile, proper storage conditions—such as sealed packaging, controlled humidity, and protection from physical damage—are critical to ensure it remains ready for implantation without contamination or degradation.

• Can this pacing lead be used in patients who require MRI scans, and if so, are there specific conditions or limitations?

  The Model 483-03 Pacing Lead is compatible with MRI environments under specific conditions, as detailed in its technical documentation. However, these conditions are not specified in the provided data, so clinicians should always refer to the manufacturer’s guidelines or labeling to confirm safe MRI protocols before proceeding. Never assume compatibility without verification.

• What regulatory pathway was followed for FDA clearance of the Model 483-03 Pacing Lead, and what does this mean for its use?

  The lead received FDA 510(k) clearance under the *Substantially Equivalent* (SESE) determination, meaning it was deemed comparable to a previously approved predicate device (a permanent pacemaker electrode) through a traditional review process. This clearance confirms the device meets FDA safety and effectiveness standards for its intended use in cardiac pacing, but clinicians should always verify current labeling for any updates or additional requirements.