28 Unipolar and Bipolar Pulse Generators

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

510(k) Number

K790452 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Micropulse 26U Pulse Generator

  Class III

  FDA 510(k) K771987 Active Cleared 2 Nov 1977

• Edwards Pacemaker 30 Unipolar Generator

  Class III

  FDA 510(k) K791751 Active Cleared 26 Sep 1979

• Micropulse 22S Pacemaker

  Class III

  FDA 510(k) K780780 Active Cleared 30 Jun 1978

• Prolith 23S Pacemaker

  Class III

  FDA 510(k) K781042 Active Cleared 27 Jul 1978

• Generator, Pulse, Cardiac 2LU

  Class III

  FDA 510(k) K770657 Active Cleared 26 Apr 1977

• Micropulse 22U

  Class III

  FDA 510(k) K780091 Active Cleared 30 Jan 1978

See all devices from Edwards Pacemaker Systems →

• What types of heart conditions is this pulse generator designed to address, and how does it work?

  This device is designed to address bradycardia and other cardiac conduction disorders by generating electrical pulses to regulate heart rhythm. It delivers unipolar and bipolar stimulation via implanted leads, ensuring consistent pacing to maintain proper heart function in patients who require artificial cardiac stimulation.

• Is this device intended for single-use or can it be reused after implantation?

  This pulse generator is classified as a reusable medical device for cardiovascular use, meaning it is intended to remain implanted within the patient long-term. It requires sterile packaging and proper handling per FDA guidelines to ensure safety and efficacy during and after surgical implantation.

• What regulatory pathway was followed for this device’s approval, and what does that mean for its use?

  This device received FDA clearance under the 510(k) pathway (K790452) with a decision of *Substantially Equivalent (SESE)* under regulation 870.3610, meaning it was deemed comparable to a legally marketed predicate device. It adheres to Class III regulatory standards and is authorized for clinical use in cardiovascular settings, ensuring compliance with strict safety and performance requirements.

• How should this device be stored before and after opening?

  Since this pulse generator is supplied in sterile packaging, it must be stored according to FDA guidelines to maintain sterility before use. After opening, it should be handled in a sterile field during surgical implantation, as it is intended for long-term internal use. Proper storage conditions (e.g., temperature, humidity) should be followed to preserve its functionality and integrity.

• What does the advisory committee classification (CV) indicate about this device’s intended use?

  The advisory committee classification (CV) refers to the *Cardiovascular* specialty, indicating that this device was reviewed by the FDA’s Cardiovascular Panel. This classification does not define its clinical indication but confirms that its development, safety, and performance were evaluated within the context of cardiovascular medical devices, ensuring alignment with regulatory standards for pacemakers and similar implants.