Pulse Generator, Unipolar, Demand

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

510(k) Number

K772240 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Universal Cutter

  Class II

  FDA 510(k) K080154 Active Cleared 20 Mar 2008

• Pacemaker Programmer #2010

  Class III

  FDA 510(k) K811217 Active Cleared 20 Jul 1981

• Microthin-Pii Bipolar Pulse Gen. #0623

  Class III

  FDA 510(k) K803034 Active Cleared 22 Dec 1980

• Astra 2, 3, 4 and 6: Chip Revision

  Not classified

  FDA 510(k) K863000 Active Cleared 19 Aug 1986

• Command Ultra I Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K831161 Active Cleared 15 Jun 1983

• Elgiloy Stylet

  Class II

  FDA 510(k) K770243 Active Cleared 14 Feb 1977

See all devices from Cardiac Pacemakers, Inc. →

• What is the primary purpose of this pulse generator in clinical practice, and how does its unipolar demand mode function differ from other pacing modes?

  This pulse generator is designed to regulate heart rhythm in patients with bradycardia or conduction disorders by delivering electrical impulses only when the heart’s natural rhythm falls below predefined thresholds. The unipolar demand mode ensures pacing is triggered *only* when intrinsic cardiac activity is insufficient, minimizing unnecessary stimulation while maintaining consistent rhythm support. This contrasts with non-demand modes, which may pace continuously regardless of the heart’s activity.

• Is this device intended for reuse, or is it strictly single-patient use? How does sterility factor into its supply and handling?

  The device is supplied sterile and explicitly intended for single-patient use only, per manufacturer guidelines. Sterility is preserved through packaging designed for one-time implantation, eliminating the need for reprocessing or reuse. Clinicians must adhere to sterile surgical techniques during implantation to maintain integrity and prevent infection.

• What considerations should clinicians keep in mind regarding storage and handling before and after surgical implantation?

  Since the device is sterile and single-use, it must be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Post-implantation, the generator is implanted subcutaneously and does not require additional handling beyond standard postoperative care. Avoid exposing the device to MRI environments unless explicitly validated by the manufacturer, as compatibility is not specified.

• Are there multiple sizes or models available for this pulse generator, or is it a standardized implantable unit?

  The device is described as a standardized implantable pulse generator, with no mention of variable sizes or models for internal implantation. It is designed for subcutaneous placement without external modifications, meaning clinicians select a single model based on compatibility with the patient’s pacing leads and clinical needs rather than sizing adjustments.