Implantable Pulse Generator

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

Full name

Generator, Pulse, Implantable

510(k) Number

K770661 ↗

FDA Product Code

DXY

FDA applicant

Med Telectronics , Ltd.

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Wedge Tip, Small, Model #030-194

  Class III

  FDA 510(k) K770283 Active Cleared 24 Feb 1977

• Wedge Tip, Small, Model #030-191

  Class III

  FDA 510(k) K770282 Active Cleared 24 Feb 1977

• Ball Tip, Model #030-185

  Class III

  FDA 510(k) K770284 Active Cleared 24 Feb 1977

• Ball Tip Electrode, Model #030-188

  Class III

  FDA 510(k) K770285 Active Cleared 24 Feb 1977

• What is the primary purpose of this implantable pulse-generator, and how does it function in a patient’s heart?

  This device is an implantable pacemaker pulse-generator, designed to deliver controlled electrical impulses to regulate abnormal heart rhythms, specifically addressing bradycardia or conduction disorders. It serves as the power source and control unit for pacemaker systems, ensuring consistent pacing signals to maintain proper cardiac function by stimulating the heart when its natural rhythm is too slow or irregular.

• Is this device intended for reuse, or is it meant for single-use after implantation?

  The device is sterile and supplied for single-use only, as explicitly stated in its description. It is intended for surgical implantation and is not designed for reuse, ensuring patient safety and sterility standards.

• What regulatory pathway does this device follow, and how is its compliance verified?

  This device is regulated under FDA 510(k) clearance (K770661) and falls under the Cardiovascular advisory committee classification. Compliance is verified through adherence to regulation number 870.3610, which sets safety and performance standards for implantable cardiac devices. The device was deemed substantially equivalent to a predicate, ensuring its design meets established benchmarks.

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

  The provided data does not specify distinct models or sizes for this pulse-generator. However, the registration numbers (e.g., 2017865, 3005334138) indicate multiple variants may exist, but no details on differences (e.g., pacing capabilities, battery life, or lead compatibility) are available in the given information. For exact specifications, consult the manufacturer’s documentation.

• How should this device be stored before implantation to maintain its integrity?

  Since the device is sterile and single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for shelf-life and storage conditions, as improper handling could compromise sterility or functionality before use.