Micropulse Model 20S

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

510(k) Number

K770211 ↗

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 is the primary purpose of the Micropulse Model 20S pacemaker, and how is it intended to be used in clinical settings?

  The Micropulse Model 20S is an implantable pacemaker pulse generator designed to deliver periodic electrical pulses for cardiac stimulation. It is intended to maintain proper heart rhythm in patients who require pacing support, typically due to conditions like bradycardia or heart block. This device is meant to be surgically implanted by qualified healthcare professionals in a clinical setting, ensuring precise and reliable cardiac pacing.

• Is the Micropulse Model 20S classified as single-use or reusable, and what does that mean for its handling?

  The provided data does not explicitly state whether the Micropulse Model 20S is single-use or reusable. However, as it is an implantable device, it is typically designed for permanent implantation within the patient’s body. This means it is not intended for repeated use outside the body, and its handling should follow standard sterile procedures for implantable devices, including proper sterilization before implantation and no reuse after removal.

• What regulatory pathway was followed for the FDA clearance of the Micropulse Model 20S, and what does this classification mean for its use?

  The Micropulse Model 20S was cleared through the FDA’s 510(k) pathway, specifically under the classification of a Class III device, which is reserved for high-risk medical devices. The clearance was granted as Substantially Equivalent (SESE) to a predicate device, meaning it was determined to have the same intended use and technological characteristics as a previously approved device. This classification ensures rigorous evaluation and compliance with safety and effectiveness standards for cardiac pacing devices.

• What types of patients or clinical specialties would primarily benefit from or use the Micropulse Model 20S?

  The Micropulse Model 20S is intended for patients requiring cardiac pacing support, such as those with bradycardia, heart block, or other conditions causing an abnormally slow heart rate. Clinically, it would be used by cardiologists, electrophysiologists, and other specialists within the cardiovascular field, who are trained in the implantation and management of pacemaker devices. The device’s regulatory classification under the medical specialty description of 'Cardiovascular' further supports its use in this specialized area.