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Intermedics Lifeline TLE Endocardial Permanent Pacemaker Electrode

by Intermedics, Inc. 510(k)

Active United States

510(k) K801172

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801172 Date1 Dec 1980ClearedStatusActive

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  • Withdrawn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)

Full name
Intermedics' Lifeline Tle Endocardial
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 Lifeline TLE Endocardial Permanent Pacemaker Electrode is a Permanent Pacemaker Electrode designed for endocardial implantation. It delivers electrical stimulation to the heart’s endocardial tissue, facilitating pacing therapy for patients with bradycardia or conduction disorders. The device is intended for use with compatible pacemaker systems to regulate cardiac rhythm in chronic indications.

This electrode is supplied sterile and intended for single-use implantation during cardiac procedures. It is classified as a Class III medical device under FDA regulations, with a Traditional 510(k) clearance (K801172) and falls under the Cardiovascular advisory committee. The device is not MRI-safe and must be handled with sterile technique prior to use, adhering to standard endovascular implantation protocols. Multiple model references are listed in regulatory records, ensuring traceability for clinical and inventory purposes.

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