Micropulse 22S Pacemaker

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

510(k) Number

K780780 ↗

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

• 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

• Analyzer, Pacer System, Psa-5

  Class II

  FDA 510(k) K781144 Active Cleared 23 Aug 1978

See all devices from Edwards Pacemaker Systems →

• What is the primary purpose of the Micropulse 22S Pacemaker, and how does it function in a clinical setting?

  The Micropulse 22S Pacemaker is designed as an implantable pulse-generator for cardiac rhythm management. It provides electrical stimulation to regulate abnormal heart rhythms by ensuring consistent and appropriate cardiac pacing, helping maintain a steady heartbeat when the heart’s natural conduction system is impaired.

• Is the Micropulse 22S Pacemaker intended for reuse, or is it meant to be implanted as a single-use device?

  The Micropulse 22S Pacemaker is explicitly supplied sterile and intended for single-use implantation only. It is not designed for reuse, as indicated in its regulatory documentation.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Micropulse 22S Pacemaker received FDA clearance through a Traditional 510(k) pathway (K780780) and is classified as a Class III medical device under FDA regulations. This means it underwent rigorous review by the Cardiovascular (CV) Advisory Committee to demonstrate substantial equivalence to a legally marketed predicate device, ensuring its safety and effectiveness for cardiac rhythm management.

• Are there any specific storage requirements or handling instructions for the Micropulse 22S Pacemaker before implantation?

  While the provided data does not specify detailed storage instructions, the device is supplied sterile and intended for surgical implantation. Standard sterile handling protocols for implantable medical devices should be followed, including protection from contamination and exposure to extreme temperatures or moisture until use.