Prolith 23S Pacemaker

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

510(k) Number

K781042 ↗

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

• 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 types of heart conditions is the Prolith 23S Pacemaker designed to treat, and how does it work?

  The Prolith 23S Pacemaker is specifically designed to address bradycardia (slow heart rate) and other cardiac conduction disorders that require chronic pacing support. It achieves this by delivering precise electrical impulses to the heart muscle, helping to regulate abnormal heart rhythms and maintain a consistent, healthy heartbeat for patients who rely on pacing therapy.

• Is the Prolith 23S Pacemaker intended for single-use or reusable implantation, and how should it be handled?

  The Prolith 23S Pacemaker is sterile and intended for single-use implantation only. Due to its classification as a sterile medical device, it must be handled according to strict sterile protocols—including proper storage, sterile packaging integrity checks, and aseptic techniques during implantation—to ensure patient safety and device efficacy.

• What regulatory pathway was followed for FDA clearance of this device, and which agency oversees its compliance?

  The Prolith 23S Pacemaker received FDA 510(k) clearance (K781042) under the traditional review pathway, with a substantially equivalent determination by the Cardiovascular (CV) Advisory Committee. It is regulated under 21 CFR 870.3610 and classified as a high-risk, life-sustaining device, ensuring rigorous oversight by the FDA for safety and performance.

• How should the Prolith 23S Pacemaker be stored to maintain its sterility and functionality?

  Since the device is sterile and single-use, it must be stored in its original, unopened packaging to preserve sterility. Storage conditions should comply with standard sterile medical device protocols—typically in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants. Always check the packaging for integrity before use to ensure the device remains uncontaminated.