MDL-201A & T DL-201A Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K790428 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K801763 Active Cleared 27 Aug 1980

• Cardiovascular Permanent Pacemaker Electrode

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• What types of heart conditions is the MDL-201A & T DL-201A Pulse Generator intended to treat, and how does it work?

  The MDL-201A & T DL-201A Pulse Generator is designed to address bradycardia (slow heart rate) and conduction system disorders by delivering regulated electrical impulses to the heart muscle. It functions as an implantable pacemaker, stimulating the heart to maintain a proper rhythm when the natural conduction system fails.

• Is the MDL-201A & T DL-201A Pulse Generator intended for single-use or can it be reused after implantation?

  The device is explicitly described as a reusable, implantable component, meaning it is intended to remain implanted in the patient long-term and is not designed for single-use or removal after surgery. It must be handled with sterile techniques during implantation and maintained according to regulatory guidelines for implantable cardiac devices.

• How should the MDL-201A & T DL-201A Pulse Generator be stored, and are there any special considerations for handling?

  The device requires storage and handling in compliance with regulatory guidelines for implantable cardiac devices. Since it is intended for sterile surgical implantation, it must be kept in a clean, controlled environment to prevent contamination. Additionally, its MRI-unspecified status means imaging protocols must be carefully reviewed to avoid interference or damage to the device during scans.

• What regulatory pathway was followed for FDA clearance of the MDL-201A & T DL-201A Pulse Generator, and what does that mean for its use?

  The device was cleared via an FDA 510(k) submission (K790428) under the Traditional review pathway, with a decision classification of *Substantially Equivalent* to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared pacemaker, ensuring it meets safety and effectiveness standards for treating bradycardia and conduction disorders.

• What are the key specifications or classifications that define this device’s role in cardiovascular applications?

  The MDL-201A & T DL-201A is classified as a Class III medical device under FDA regulations (regulation number 870.3610), indicating it carries higher risk and requires stringent oversight. It falls under the product code DXY and was reviewed by the Cardiovascular (CV) Advisory Committee, confirming its specialized role in regulating heart rhythm for patients with pacing-dependent conditions.