Polyflex 483-09 Endocardial Implantable Pacinglead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K854069 ↗

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 Polyflex 483-09 Endocardial Implantable Pacemaker Lead designed for, and where is it typically placed in the body?

  The Polyflex 483-09 is specifically designed for endocardial implantation to deliver electrical stimulation to the heart, ensuring precise myocardial contact. It is most commonly used in pacing applications within the right ventricle or atrium to support cardiac rhythm management. The flexible design allows for accurate positioning and long-term stability during therapy.

• Is the Polyflex 483-09 lead intended for single-use or reusable applications, and how should it be handled?

  The Polyflex 483-09 is supplied sterile and intended for single-use only by qualified healthcare professionals in controlled settings like a cardiac catheterization lab or operating room. Due to its sterile packaging and endocardial implantation purpose, reuse is not recommended or supported by the manufacturer.

• Can this pacemaker lead be used in patients who require MRI scans, and what considerations should be taken?

  The Polyflex 483-09 is compatible with MRI environments under specific conditions, as outlined in the manufacturer’s instructions. However, MRI use must strictly follow Intermedics’ guidelines to ensure patient safety, as electromagnetic interference could affect lead performance or pose risks. Always verify compatibility with your MRI facility’s protocols before use.

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

  The Polyflex 483-09 received FDA clearance through a 510(k) Traditional Review (K854069) under the Cardiovascular (CV) Advisory Committee, demonstrating substantial equivalence to prior-generation pacemaker leads. This classification confirms it meets FDA standards for permanent pacemaker electrodes (21 CFR 870.3680) and is intended for qualified professionals in clinical settings like catheterization labs or ORs.