Prima 236-02 Nonprogrammable Cardiac Pacemaker Pulse-Generator

No FDA recalls on record, checked 22 Oct 2026.

Full name

Prima 236-02 Nonprogrammable Cardiac

510(k) Number

K841404 ↗

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 Prima 236-02 Nonprogrammable Cardiac Pacemaker Pulse-Generator, and who would benefit from it?

  The Prima 236-02 is designed to provide fixed, non-adjustable electrical pacing to regulate heart rhythm in patients with bradycardia or conduction disorders. It is intended for patients who require consistent cardiac pacing without the need for programmable adjustments, ensuring reliable heart rate support in those with slow or irregular heartbeats.

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

  The Prima 236-02 is supplied sterile and intended for single-use implantation only. After use, it should not be reused or reprocessed, as this could compromise patient safety and device integrity.

• Can this pacemaker be adjusted or reprogrammed after implantation, and what safety precautions should be taken during handling?

  This device is nonprogrammable, meaning it delivers a fixed pacing output without adjustable settings. Due to its MRI-unsafe classification, extreme care must be taken to avoid physical damage during handling, storage, or implantation to ensure proper functionality.

• How should the Prima 236-02 be stored to maintain sterility and functionality before use?

  The device must be stored following sterile procedures to preserve its integrity. Since it is supplied sterile for single-use, it should remain in its original packaging until implantation, protected from contamination, moisture, and mechanical stress.

• What regulatory pathway does this device follow, and what classification does it hold under FDA standards?

  The Prima 236-02 is classified as a Class III medical device under FDA nomenclature (product code DXY) and was granted 510(k) clearance (K841404) via a traditional review process. It falls under the Cardiovascular advisory committee and is regulated under 21 CFR 870.3610, ensuring compliance with strict manufacturing and performance standards.