Lifeline TLE 476-04

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K843393 ↗

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 476-04 and how does it function in the body?

  The Lifeline TLE 476-04 is a permanent pacemaker electrode designed to interface with cardiac pacemakers. It delivers controlled electrical impulses to the heart to regulate abnormal rhythms, ensuring proper cardiac function by maintaining a steady pacing signal when the heart’s natural conduction system fails.

• Is this device intended for reuse or single-use, and what does that mean for surgical planning?

  The Lifeline TLE 476-04 is sterile and intended for single-use implantation only. This means it must be used once and discarded after surgery, requiring sterile handling and packaging protocols to prevent contamination before and during implantation.

• How should the device be stored to ensure it remains effective before use?

  Since it is a sterile medical device, the Lifeline TLE 476-04 must be stored according to sterile medical device protocols—typically in its original packaging, protected from moisture, extreme temperatures, and physical damage until immediately before surgical use.

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

  The device was cleared via a Traditional 510(k) pathway under FDA classification DTB (Permanent Pacemaker Electrode) with a Substantially Equivalent (SESE) determination. This means it was reviewed by the Cardiovascular (CV) Advisory Committee and deemed comparable to legally marketed predecessors, ensuring compliance with safety and performance standards for cardiac pacing applications.