Lifeline Tle (Traebecular Lodging Elec

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K792300 ↗

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 Trabecular Lodging Electrode and how does it differ from other pacemaker leads?

  The Lifeline TLE is designed specifically for transvenous implantation in the right ventricle, where it anchors within the trabecular network to provide stable lead fixation. Unlike traditional pacemaker leads, its trabecular lodging mechanism enhances reliability in signal transmission for chronic cardiac rhythm management, ensuring long-term stability for patients requiring pacing support.

• Is the Lifeline TLE intended for single-use or reusable applications, and what does this mean for clinical workflow?

  The Lifeline TLE is supplied sterile and intended for single-use implantation only. This means each device is pre-sterilized for one-time use in a patient, reducing the risk of infection and ensuring compliance with sterile field protocols in electrophysiology labs or catheterization suites.

• How should the Lifeline TLE be stored, and are there any specific handling instructions provided?

  While the provided data does not specify storage conditions in detail, the device is sterile at time of manufacture and supplied with surgical instructions for use. Clinicians should follow Intermedics’ included guidelines to maintain sterility until implantation, typically involving protective packaging and avoiding contamination before use.

• What regulatory pathway was followed for FDA clearance of the Lifeline TLE, and what does this imply for its safety and efficacy?

  The Lifeline TLE received FDA 510(k) clearance (K792300) under the Traditional review pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This classification indicates the device met FDA standards for safety and effectiveness as a Class III medical device, requiring rigorous pre-market evaluation for high-risk cardiovascular applications like permanent pacemaker electrodes.