Model 480-01 Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844270 ↗

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 480-01 Pacing Lead, and how is it implanted in the body?

  The Model 480-01 Pacing Lead is designed as a permanent pacemaker electrode to deliver electrical impulses directly to the heart. It is intended for transvenous insertion, meaning it is threaded through a vein (typically the subclavian or jugular vein) and positioned within the heart chambers to ensure reliable electrical conduction for cardiac pacing.

• Is the Model 480-01 Pacing Lead meant for single-use or can it be reused after sterilization?

  The Model 480-01 Pacing Lead is explicitly supplied for single-use only and is provided in a sterile condition. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and functionality. Always follow the manufacturer’s guidelines for handling and storage to maintain integrity.

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

  Yes, the Model 480-01 Pacing Lead is approved for use in MRI environments, though its compatibility is contingent on adherence to the manufacturer’s specified guidelines. These guidelines likely include restrictions on MRI strength, patient positioning, and monitoring protocols to ensure safety during imaging. Always verify the latest instructions from Intermedics, Inc. before use.

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

  The Model 480-01 Pacing Lead received FDA 510(k) clearance (K844270) under a Substantially Equivalent (SESE) decision, meaning it was deemed comparable to a legally marketed predicate device. Clinically, this indicates the device has undergone rigorous review for safety and effectiveness, but it does not imply any specific clinical indication—only that it meets regulatory standards for transvenous cardiac pacing as described in its labeling.

• How should the sterile packaging of the Model 480-01 Pacing Lead be stored to preserve its condition before use?

  The sterile packaging must be stored according to the manufacturer’s guidelines to maintain sterility and functionality. Typically, this involves keeping the lead in its original, unopened packaging in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants. Avoid exposing the packaging to moisture or physical damage, as this could compromise sterility before implantation.