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Permanthane #866 Bipolar Coaxial

by Pacesetter Systems 510(k)

Active United States

510(k) K832987

Overview

The Permanthane #866 Bipolar Coaxial is a Permanent Pacemaker Electrode, designed for transvenous implantation to deliver electrical stimulation to the heart. It features a bipolar coaxial lead configuration, combining a central electrode with an outer return electrode to facilitate precise pacing and sensing of cardiac activity.

This device is intended for single-use in cardiac electrophysiology procedures, supplied sterile and intended for implantation via the venous system. It is classified as a Class III medical device under FDA regulations (21 CFR 870.3680) and holds a Traditional 510(k) clearance (K832987) for cardiovascular applications. Compliance with sterility and manufacturing standards ensures safe use in clinical settings.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK832987 Date20 Oct 1983ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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

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Questions

  • Is the Permanthane #866 Bipolar Coaxial lead designed for reuse in multiple patients, or is it intended for single-use only?

    The Permanthane #866 Bipolar Coaxial is explicitly designed for single-use in cardiac electrophysiology procedures. It is supplied sterile and intended for implantation via the venous system, ensuring patient safety and compliance with clinical standards for permanent pacemaker electrodes.

  • What types of cardiac procedures is this lead approved for, and how is it implanted?

    This lead is approved for transvenous implantation in the venous system to deliver precise electrical stimulation and sensing of cardiac activity. It is intended for use in permanent pacemaker procedures, where it facilitates bipolar pacing and sensing in patients requiring cardiac rhythm management.

  • How is the Permanthane #866 Bipolar Coaxial lead supplied, and what does that mean for clinical workflow?

    The lead is supplied sterile, which means it is pre-packaged and ready for immediate use in the operating room or electrophysiology lab. This eliminates the need for additional sterilization steps, streamlining workflow and ensuring sterility before implantation.

  • What regulatory pathway was followed for this device’s approval, and which committee reviewed it?

    The Permanthane #866 Bipolar Coaxial received a Traditional 510(k) clearance (K832987) under the FDA’s 510(k) pathway, demonstrating it is substantially equivalent to a legally marketed predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device under 21 CFR 870.3680 for cardiovascular applications.