Model 473-03 Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844272 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

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  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• Is the Model 473-03 Pacing Lead designed for reuse or single-use, and how should it be handled to maintain sterility?

  The Model 473-03 Pacing Lead is explicitly designed for single-use implantation only. It is supplied sterile, so it must be handled using aseptic techniques to preserve sterility. Follow the manufacturer’s instructions for opening, transfer, and implantation to avoid contamination, as any compromise could risk infection or device failure.

• What types of patients is this pacing lead intended to support, and what clinical condition does it address?

  This lead is intended for patients with bradycardia or conduction disorders that require cardiac pacing. It delivers electrical impulses to stimulate the heart muscle, helping to regulate and coordinate contractions when the natural pacemaker (e.g., the sinoatrial node) is dysfunctional or nonfunctional.

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

  Yes, the Model 473-03 Pacing Lead is compatible with MRI environments under specific conditions. However, its use during MRI requires strict adherence to the manufacturer’s labeling and guidelines to ensure patient safety. Always verify compatibility with the MRI facility’s protocols and consult the device’s instructions for proper precautions.

• How is the Model 473-03 Pacing Lead supplied, and what should clinicians consider when storing it?

  The lead is supplied sterile and ready for single-use implantation. Storage must follow the manufacturer’s instructions to maintain sterility and functionality, including protection from moisture, extreme temperatures, and physical damage. Ensure the packaging remains intact until immediate use to prevent contamination.