Suprima 253-21 Implantable Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K844793 ↗

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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• What is the primary clinical purpose of the Suprima 253-21 Implantable Pulse Generator, and how does it address cardiac rhythm disorders?

  The Suprima 253-21 Implantable Pulse Generator is designed to replace the heart’s natural pacemaker system by delivering controlled electrical pulses to correct intermittent or continuous cardiac rhythm disorders, such as bradycardia (slow heart rate) or conduction block. It functions as a substitute pacemaker, ensuring consistent heart rhythm by stimulating the heart muscle electrically when needed.

• Is the Suprima 253-21 intended for single-use or reusable implantation, and what are the sterility guarantees?

  The Suprima 253-21 is explicitly intended for single-use implantation and is supplied sterile, adhering to FDA regulations for pacemaker pulse generators (870.3610). This ensures safety and sterility for one-time surgical use without requiring reprocessing.

• How is this device regulated by the FDA, and what does the clearance classification mean for its use?

  The Suprima 253-21 holds a Traditional 510(k) clearance (K844793) under FDA classification as a Class III Implantable Pacemaker Pulse-Generator, determined to be *substantially equivalent* to a predicate device. This means it meets FDA standards for safety and effectiveness as an implantable cardiac rhythm management tool, regulated under the same framework as comparable pacemakers.

• What medical specialty is primarily responsible for the evaluation or use of this device, and why?

  The Suprima 253-21 falls under the Cardiovascular medical specialty, as indicated in regulatory records. This reflects its direct application in treating cardiac rhythm disorders, where cardiologists or electrophysiologists typically oversee implantation, programming, and patient management.

• Are there any specific storage requirements mentioned for the Suprima 253-21 before implantation?

  The regulatory data does not provide explicit details on storage conditions (e.g., temperature, humidity, or shelf life) for the Suprima 253-21. However, as a sterile, single-use implantable device, it should be stored according to standard medical device protocols to maintain sterility and functionality until use.