Quantum Unipolar Multi-Programmable Implantable Pacemaker Pulse-Generator

No FDA recalls on record, checked 22 Oct 2026.

Full name

Quantum, Unipolar, Multi-Programmable

510(k) Number

K841073 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

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 primary purpose of the Quantum Unipolar Multi-Programmable Implantable Pacemaker Pulse-Generator, and who would benefit from it?

  The Quantum device is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients with bradycardia or conduction disorders requiring artificial pacing. It is intended for use in clinical settings where unipolar pacing is required to maintain proper heart function.

• Is this device intended for reuse, or is it meant to be implanted once and discarded?

  The Quantum device is supplied sterile and intended for single-use implantation only. This means it is not designed for reuse, ensuring patient safety and sterility standards are maintained during the procedure.

• How is this pacemaker programmed, and what type of pacing does it provide?

  The Quantum is a multi-programmable device, meaning it can be adjusted to deliver unipolar pacing stimuli tailored to the patient’s needs. This flexibility allows clinicians to optimize pacing parameters for individual cardiac conditions.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Quantum device was cleared under the traditional 510(k) pathway and is classified as a Class III medical device. It falls under FDA regulation number 870.3610 and product code DXY, reflecting its critical role in life-sustaining cardiac rhythm management.

• Are there any special handling or storage requirements for this device before implantation?

  Since the Quantum is supplied sterile and intended for single-use, it must be stored in its original packaging until implantation to preserve sterility. Proper storage conditions (e.g., temperature, humidity) should follow manufacturer guidelines to ensure device integrity before use.