Polyflex Epicardial 439-04 Implant Pacing Lead

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Polyflex(R) Epicardial 439-04 Implant Pacing Lead

510(k) Number

K874531 ↗

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 types of patients is this epicardial pacing lead designed for, and how is it implanted?

  This lead is designed for patients requiring cardiac pacing due to bradycardia or conduction system disorders. It is intended for surgical implantation during open-chest procedures, where it is positioned on the epicardial surface of the heart to deliver electrical stimulation and regulate heart rhythm.

• Is the Polyflex Epicardial 439-04 Implant Pacing Lead reusable or single-use, and how is it supplied?

  The lead is supplied sterile and intended for single-use only. It comes pre-packaged for immediate surgical use, ensuring sterility and minimizing risk of contamination.

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

  The Polyflex Epicardial 439-04 Implant Pacing Lead received FDA 510(k) clearance (K874531) under the traditional review pathway, with a decision of *Substantially Equivalent* (SESE). It is classified as a Class III medical device under FDA regulations, reflecting its role in life-sustaining or life-supporting functions.

• How is this lead differentiated from other permanent pacemaker electrodes, and what surgical context is it intended for?

  This lead is specifically designed for epicardial placement, meaning it is surgically positioned on the outer surface of the heart during open-chest procedures. Unlike transvenous leads, it requires direct access to the heart tissue, making it suitable for cases where epicardial pacing is clinically indicated, such as in congenital heart disease or certain arrhythmias.