Biotronik DN Unipolar PE-60/4-DN Electrode

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Biotronik Dn Unipolar Pe-60/4-Dn &

510(k) Number

K833098 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Biotronik D2K Unipolar PE-60/4

  Class III

  FDA 510(k) K833104 Active Cleared 19 Oct 1983

• Leptos Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K841635 Active Cleared 3 Aug 1984

• EDP-20 Pacemaker

  Class III

  FDA 510(k) K860036 Active Cleared 12 Jan 1987

• Pulse Generator

  Class III

  FDA 510(k) K821073 Active Cleared 7 May 1982

• Biotronik Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K863480 Active Cleared 23 Sep 1986

• Neos-M VS-1 Pulse Generator

  Class III

  FDA 510(k) K863879 Active Cleared 10 Dec 1986

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• What is the primary use of the Biotronik DN Unipolar PE-60/4-DN Electrode in clinical practice?

  This device is designed for transvenous implantation to deliver pacing stimuli to the heart in patients requiring permanent cardiac rhythm management. Its unipolar configuration and four ring electrodes allow for precise pacing support, making it suitable for long-term use in patients with bradycardia or other indications necessitating a permanent pacemaker system.

• Is this pacemaker electrode intended for reuse, or is it meant to be used only once?

  The Biotronik DN Unipolar PE-60/4-DN Electrode is explicitly labeled for single-use only. It must be implanted under sterile conditions in a clinical setting, and reuse is not permitted to maintain safety and efficacy standards.

• How should this device be stored to ensure sterility and functionality before use?

  Storage must follow the manufacturer’s guidelines to preserve sterility and functionality. Since it is single-use and intended for sterile implantation, it should be kept in its original packaging until immediately before use, in a clean, dry environment away from direct sunlight or extreme temperatures.

• What is the length of the lead, and how does this affect its placement in the body?

  The lead has a 60-centimeter length, which provides sufficient reach for transvenous implantation—typically inserted through a vein (e.g., subclavian or cephalic) and advanced into the heart. This length ensures flexibility for proper positioning while minimizing risks associated with overly long or short leads.

• What regulatory pathway was followed for FDA clearance of this device?

  The Biotronik DN Unipolar PE-60/4-DN Electrode received FDA 510(k) clearance under the Traditional Review pathway, with a decision classification of Substantially Equivalent (SESE) to a predicate device. It falls under Class III regulatory classification and was reviewed by the Cardiovascular (CV) Advisory Committee.