Pacemaker, Prolith 23U Pulse Generator

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

510(k) Number

K780238 ↗

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 cardiac rhythm disorders can the Prolith 23U Pulse Generator address, and how does it regulate heart function?

  The Prolith 23U Pulse Generator is designed to address intermittent and continuous cardiac rhythm disorders by substituting for the heart’s natural pacing system. It generates periodic electrical pulses to maintain proper heart rhythm and can operate in triggered, inhibited, or asynchronous modes, allowing it to adapt to different clinical needs. This flexibility helps regulate heart function in patients with bradycardia or other rhythm abnormalities.

• Is the Prolith 23U Pulse Generator intended for single-use or reusable applications, and what sterility precautions should be taken?

  The Prolith 23U is supplied sterile for single-use only, meaning it is not designed for reuse. To ensure patient safety and device functionality, it must be handled and stored according to sterile medical device protocols, including proper packaging integrity and environmental controls before implantation.

• How is the Prolith 23U Pulse Generator regulated, and what does its FDA clearance status indicate?

  The Prolith 23U is regulated under FDA 510(k) clearance (K780238) and classified as a Class III device, indicating it carries higher risk and requires stringent oversight. The clearance status means it has been determined substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness requirements for implantable pacemaker pulse generators.

• What storage and handling requirements should be followed for the Prolith 23U Pulse Generator to maintain its integrity?

  Since the Prolith 23U is sterile and single-use, it must be stored in its original packaging to preserve sterility. Handling should follow sterile medical device protocols, including protection from contamination, extreme temperatures, and physical damage. Always check expiration dates and ensure the device is not exposed to moisture or direct sunlight before use.