Lifeline TLE Endocardial Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K792604 ↗

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

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  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. →

• What is the primary purpose of the Lifeline TLE Endocardial Pacing Lead and how does it function in the body?

  The Lifeline TLE Endocardial Pacing Lead is designed to deliver electrical stimulation directly to the heart’s inner lining (endocardium) via transvenous implantation. It helps regulate heart rhythm by transmitting pacing pulses, ensuring synchronized contractions in patients with bradycardia or conduction disorders. This prevents irregular or slow heartbeats, maintaining proper cardiac function.

• Is this device intended for single-use only, or can it be reused under certain conditions?

  The Lifeline TLE Endocardial Pacing Lead is supplied sterile and intended for single-use, though the manufacturer provides guidelines for potential reuse. However, adherence to sterile field protocols is critical to maintain device integrity and patient safety, as reuse must follow specific operational instructions.

• What are the key model references for this device, and how do I identify the correct one for my patient?

  Multiple model references exist for the Lifeline TLE Endocardial Pacing Lead, including identifiers like 3002618605, 1028232, and others listed in the registration records. The correct model should be selected based on clinical requirements (e.g., lead length, electrode configuration) and compatibility with the patient’s anatomy and pacing system. Always verify with the manufacturer or medical device specialist to ensure proper fit and function.

• How should the Lifeline TLE Endocardial Pacing Lead be stored to preserve sterility and functionality?

  To maintain sterility and integrity, the device must be stored in its original packaging under clean, dry conditions away from direct sunlight or extreme temperatures. Sterile field protocols must be followed during handling, as the lead is supplied sterile and intended for single-use (or reuse per guidelines). Avoid contamination or physical damage to the lead’s components before implantation.

• Can this device be used in patients who require MRI scans, and what conditions apply?

  Yes, the Lifeline TLE Endocardial Pacing Lead is compatible with MRI environments under specific conditions outlined in its labeling. However, the exact parameters (e.g., MRI strength, safety protocols) must be followed to prevent interference or damage to the device. Always consult the manufacturer’s MRI safety guidelines and the patient’s specific lead model before proceeding with an MRI.