Lifeline Unipolar Lead #487-05

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K823508 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 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

• Poly Flex Implantable Pacing Lead

  Class III

  FDA 510(k) K802294 Active Cleared 3 Apr 1985

See all devices from Intermedics, Inc. →

• What is the primary purpose of the Lifeline Unipolar Lead #487-05 and how does it function in the body?

  The Lifeline Unipolar Lead #487-05 is designed as a permanent pacemaker electrode for implantation in the cardiovascular system. It delivers unipolar pacing signals to regulate abnormal heart rhythms, ensuring consistent cardiac function in patients who require chronic pacing therapy. By stimulating the heart electrically, it helps maintain proper heart rate and rhythm for those with conditions like bradycardia or other arrhythmias.

• Is this device intended for reuse or single-use, and what are the implications for clinical settings?

  The Lifeline Unipolar Lead #487-05 is sterile and intended for single-use only. This means it is meant to be implanted once by qualified healthcare professionals in controlled environments like hospitals or cardiac care units. Single-use design ensures patient safety by minimizing infection risks associated with reuse, though it also requires proper inventory management to account for each procedure.

• What regulatory pathway was followed for FDA clearance of this device, and which committee was involved?

  The Lifeline Unipolar Lead #487-05 received FDA 510K clearance under the Traditional Review pathway, determined to be substantially equivalent (SESE) to a predicate device. The Cardiovascular (CV) Advisory Committee was involved in reviewing its safety and effectiveness, aligning with its classification as a Class III medical device under 21 CFR 870.3680. This process ensures compliance with rigorous standards for pacemaker electrodes.

• Does this lead come with specific instructions for proper surgical placement, and what should clinicians consider during implantation?

  Yes, the Lifeline Unipolar Lead #487-05 is distributed with detailed surgical instructions to guide proper placement within the heart. Clinicians should follow these instructions closely to ensure accurate positioning for effective pacing. Since it is designed for permanent implantation, factors like lead stability, electrode contact with cardiac tissue, and avoidance of phrenic nerve stimulation must be carefully managed during the procedure.