Implantable Programmable Pulse Generator

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

510(k) Number

K854560 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• What is the primary clinical purpose of this implantable pulse generator and which patient conditions does it address?

  This device is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients with bradycardia or conduction disorders. It acts as an implantable pacemaker pulse-generator to ensure proper pacing when the heart’s natural electrical system is compromised.

• Is this device intended for reuse or is it single-use only, and how is it supplied?

  The device is supplied sterile and explicitly intended for single-use only, meaning it is not designed for reuse after implantation. This ensures patient safety and compliance with regulatory standards.

• What regulatory pathway was followed for FDA clearance, and how does this affect its classification?

  The device underwent a Traditional 510(k) review through the FDA’s Cardiovascular (CV) Advisory Committee, receiving a Substantially Equivalent (SESE) decision. It is classified as a Class III medical device under the Implantable Pacemaker Pulse-Generator category (product code: DXY), adhering to 21 CFR 870.3610.

• How should this device be stored before use, and are there any special handling requirements?

  While the data does not specify storage conditions, as a sterile, single-use implantable device, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer instructions for optimal preservation until implantation.