Intermedics Polyflex Pacing Lead #480-01

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K820267 ↗

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 Intermedics Polyflex Pacing Lead #480-01 and how does it function in the body?

  The Intermedics Polyflex Pacing Lead #480-01 is designed as a permanent pacemaker electrode to regulate heart rhythm in patients with bradycardia or conduction disorders. It delivers controlled electrical impulses to stimulate the heart muscle, ensuring consistent contractions and maintaining proper cardiac function. Implanted within the heart chambers—typically via the venous system—it provides chronic pacing support for patients whose natural electrical signals are insufficient.

• Is this device intended for reuse, or is it meant to be implanted as a single-use item?

  This lead is explicitly intended for single-use implantation. It is supplied sterile and packaged for surgical use, requiring aseptic techniques during the procedure. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety.

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

  The Intermedics Polyflex Pacing Lead #480-01 was cleared through the FDA 510(k) pathway under the classification of a Class III medical device, with a Traditional review process. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its designation as a permanent pacemaker electrode for cardiovascular applications. The clearance number is K820267, and the decision was dated April 3, 1985.

• How should this device be stored before use, and what precautions should be taken?

  The lead is supplied sterile and packaged for surgical use, so it must be stored in its original, unopened packaging to maintain sterility. Storage should follow manufacturer guidelines for medical devices, typically in a clean, dry environment protected from extreme temperatures, moisture, or physical damage. Avoid exposure to direct sunlight or contaminants, and adhere to expiration dates if applicable. Always verify the packaging integrity before use.