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Intermedics Polyflex-Model 483-04 Lead

by Intermedics, Inc. 510(k)

Active United States

510(k) K812991

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK812991 Date16 Nov 1981ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DTB
Device Class
Class III
Regulation
21 CFR Part 870.3680
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Intermedics Polyflex Model 483-04 Lead is a Permanent Pacemaker Electrode, designed for implantation in the cardiovascular system to facilitate cardiac pacing. This device delivers electrical impulses to regulate heart rhythm in patients with bradycardia or other conduction disorders, ensuring consistent and reliable cardiac function.

This lead is intended for single-use implantation and is supplied sterile for direct use in cardiac procedures. It is classified as a Class III medical device under FDA regulations, with a Traditional 510(k) clearance through the Cardiovascular Advisory Committee. The device is compatible with MRI environments under specific conditions as outlined in its labeling, and storage instructions require protection from moisture and extreme temperatures.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is the Intermedics Polyflex Model 483-04 Lead designed for reuse in patients, or is it intended for single-use only?

    The Intermedics Polyflex Model 483-04 Lead is explicitly designed for single-use implantation and is supplied sterile for direct use in cardiac procedures. This ensures patient safety and sterility during the procedure, as reuse is not recommended or supported by the manufacturer.

  • What storage conditions should be followed to maintain the integrity of the Intermedics Polyflex Model 483-04 Lead before use?

    The lead must be stored in a way that protects it from moisture and extreme temperatures. Proper storage conditions are critical to preserve its sterility and functionality, as outlined in the device’s labeling instructions.

  • Can this lead be used in patients who require MRI scans, and if so, are there specific conditions that must be met?

    Yes, the Intermedics Polyflex Model 483-04 Lead is compatible with MRI environments, but only under specific conditions as detailed in its labeling. Clinicians should strictly follow the manufacturer’s guidelines to ensure safe use during MRI procedures.

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

    The Intermedics Polyflex Model 483-04 Lead received FDA clearance through a Traditional 510(k) pathway, with a substantial equivalence determination (SE). The submission was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device under FDA regulations.