Prolith Model 21S Cardiac Pulse Gen.

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

510(k) Number

K770212 ↗

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 clinical purpose of the Prolith Model 21S Cardiac Pulse Generator, and how does it achieve this?

  The Prolith Model 21S Cardiac Pulse Generator is designed to regulate heart rhythm by delivering controlled electrical impulses to the heart muscle. This helps maintain proper cardiac function in patients experiencing bradycardia (slow heart rate) or other conduction disorders, ensuring consistent and effective heart contractions.

• Is the Prolith Model 21S Cardiac Pulse Generator intended for reuse, or is it meant to be implanted only once?

  The Prolith Model 21S Cardiac Pulse Generator is explicitly intended for single-use implantation only. It is not designed for reuse and must be surgically implanted by a qualified healthcare professional in a clinical setting.

• How is the Prolith Model 21S Cardiac Pulse Generator supplied, and what precautions should be taken during handling?

  The device is supplied sterile and packaged for surgical use. Since it is intended for implantation, it must be handled under sterile conditions to prevent contamination before and during the procedure. Only trained medical professionals should open and prepare the device for use.

• What regulatory pathway was followed for the FDA clearance of the Prolith Model 21S Cardiac Pulse Generator, and what does this mean for its clinical use?

  The Prolith Model 21S received FDA 510(k) clearance (K770212) in 1977 under the Traditional 510(k) review pathway, with a decision classification of *Substantially Equivalent* to a predicate device. This means the FDA determined it had the same intended use and technological characteristics as a previously cleared device, ensuring it meets regulatory standards for safety and effectiveness as an implantable pacemaker pulse-generator.