Pulse Generator 728, 728B & 728l

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

510(k) Number

K841226 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Servo Gas Monitor 120

  Class II

  FDA 510(k) K861625 Active Cleared 2 May 1986

• Master Program Flow & Pressure CO2 & Lung Monitor

  Class II

  FDA 510(k) K861707 Active Cleared 19 Jun 1986

• Siemens-Elema Pulse Generator 625

  Class III

  FDA 510(k) K801508 Active Cleared 16 Sep 1980

• Endocardial Leads 414S & 515S

  Class III

  FDA 510(k) K802816 Active Cleared 16 Jan 1981

• Gas Supply Manifold Siemens-Elema Ab

  Class I

  FDA 510(k) K840326 Active Cleared 7 Jun 1984

• Pacemaker Sys. Analyzer 378

  Class II

  FDA 510(k) K832959 Active Cleared 14 Nov 1983

See all devices from Siemens Elema AB →

• What types of patients is the Pulse Generator 728 series intended to support, and how does it work?

  The Pulse Generator 728, 728B, and 728L are designed for patients with bradycardia or conduction system disorders who require pacing support. These devices regulate cardiac rhythm by delivering precise electrical impulses to the heart, ensuring consistent and reliable heart function. They are specifically classified as Implantable Pacemaker Pulse-Generators and are intended for use in controlled clinical settings like operating rooms or electrophysiology labs.

• Are these devices single-use or reusable, and what does that mean for handling and disposal?

  The Pulse Generator 728 series is explicitly labeled as single-use devices. This means each unit is intended for one-time use in a single patient and must be disposed of as medical waste after implantation. Proper handling and disposal protocols must be followed to ensure patient safety and compliance with clinical waste regulations.

• How are these devices supplied, and do they come sterile?

  The Pulse Generator 728, 728B, and 728L are supplied as part of a cardiovascular implant system and are non-sterile. They are not intended for direct patient implantation without sterilization or preparation in a controlled clinical setting. Sterilization procedures must be performed prior to use, as dictated by standard medical practices for implantable devices.

• What regulatory pathway was followed for clearance of these devices, and what does that mean for clinicians?

  The Pulse Generator 728 series received FDA clearance through a Traditional 510(k) pathway, with a decision of *Substantially Equivalent* (SESE) issued in 1984. This means the device was determined to be as safe and effective as a legally marketed predicate device (an earlier pacemaker pulse-generator). Clinicians can rely on this classification, which confirms the device’s compliance with FDA standards for Implantable Pacemaker Pulse-Generators under product code DXY.

• What are the key differences between the 728, 728B, and 728L models, and how might a clinician choose between them?

  The provided data does not specify technical differences between the 728, 728B, and 728L models beyond their shared classification as Implantable Pacemaker Pulse-Generators. However, the models are likely variations in design, programming capabilities, or battery life, which would be determined by the manufacturer’s technical documentation. Clinicians should consult the manufacturer’s instructions for detailed specifications, such as pacing modes, lead compatibility, or battery longevity, to select the appropriate model for a patient’s specific needs.