Carciac Pulse Generator 254-20

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K841075 ↗

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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See all devices from Intermedics, Inc. →

• What is the primary purpose of the Cardiac Pulse Generator 254-20 and which patients would benefit from it?

  The Cardiac Pulse Generator 254-20 is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle, specifically for patients with bradycardia or conduction disorders. It is intended for use in clinical settings by qualified healthcare professionals to manage abnormal slow heart rates or electrical signal issues in the heart.

• Is the Cardiac Pulse Generator 254-20 intended for reuse or is it meant to be used only once?

  The Cardiac Pulse Generator 254-20 is explicitly intended for single-use implantation only. It is supplied sterile and must be handled with sterile techniques prior to use, ensuring it remains suitable for one-time surgical implantation by healthcare professionals.

• How should the Cardiac Pulse Generator 254-20 be stored to maintain its sterility and functionality?

  The device must be stored following the manufacturer’s guidelines to preserve sterility and functionality. Since it is supplied sterile and intended for single-use, proper storage conditions—such as avoiding contamination, extreme temperatures, or prolonged exposure to moisture—are critical to ensure it remains ready for implantation when needed.

• Can this device be used in an MRI environment, or are there specific safety concerns?

  The Cardiac Pulse Generator 254-20 is non-MRI-compatible, meaning it should not be used in magnetic resonance imaging environments. The presence of this device could pose risks during MRI procedures, including potential interference or injury, so patients must avoid MRI scans unless specifically cleared by their healthcare provider.

• What regulatory pathway was followed for the approval of this device, and which committee reviewed it?

  The Cardiac Pulse Generator 254-20 was cleared through the FDA’s 510(k) pathway under the classification of a Class III medical device, with a Traditional review. The device was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be Substantially Equivalent (SESE) to a predicate device, ensuring compliance with FDA regulations for implantable pacemaker pulse-generators.