Lifeline TLE 484-02

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K843394 ↗

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 484-02 and how does it function in the body?

  The Lifeline TLE 484-02 is a permanent pacemaker electrode designed to regulate abnormal heart rhythms by delivering controlled electrical impulses to the heart muscle. It is implanted within the cardiovascular system to stimulate the heart when natural electrical signals are insufficient, ensuring consistent and appropriate heartbeating for patients with bradycardia or other pacing-dependent conditions.

• Is the Lifeline TLE 484-02 intended for single-use or can it be reused after implantation?

  The Lifeline TLE 484-02 is explicitly described as a reusable medical implant, meaning it is intended to remain implanted in the patient long-term. Unlike disposable devices, it is not meant for single-use and is designed for sustained cardiac pacing functionality over an extended period.

• What regulatory pathway was followed for FDA clearance of this device, and what class does it fall under?

  The Lifeline TLE 484-02 was cleared through the FDA 510(k) pathway under the Traditional review process, with a decision date of September 24, 1984. It is classified under FDA product code DTB and falls under Class III regulatory requirements, indicating it is a higher-risk device requiring strict regulatory oversight due to its role in life-sustaining cardiac pacing.

• Are there any specific storage instructions or considerations for handling the Lifeline TLE 484-02 before implantation?

  While the provided data does not specify detailed storage instructions, as a reusable implantable device, proper handling and sterilization protocols (e.g., autoclave or ethylene oxide) are critical before implantation to ensure patient safety. Clinicians should follow manufacturer guidelines (Intermedics, Inc.) for sterilization and storage to maintain device integrity and functionality.