Prima-Unipolar Cardiac Pulse Generat

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K832914 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary clinical purpose of the Prima Unipolar Cardiac Pulse Generator, and how does it achieve this?

  The Prima Unipolar Cardiac Pulse Generator is designed to regulate abnormal slow heart rhythms (bradycardia) or cardiac conduction disorders by delivering controlled electrical impulses to the heart muscle. It functions as an implantable pacemaker, stimulating the heart at a preset rate to maintain proper cardiac rhythm when the natural conduction system fails.

• Is this device intended for reuse after a single implantation, and what does that mean for clinical workflows?

  Yes, the Prima Unipolar Cardiac Pulse Generator is supplied sterile and intended for single-use implantation only. This means each device is meant to be implanted once in a patient and should not be reused, ensuring patient safety and sterility. Clinicians should follow standard sterile procedures during implantation and dispose of the device appropriately after use.

• What regulatory pathway was followed for FDA clearance of this device, and what does that imply about its safety and equivalence?

  The Prima Unipolar Cardiac Pulse Generator received FDA clearance through a Traditional 510(k) pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This implies that the device’s design and performance were determined to be as safe and effective as a previously cleared pacemaker, meeting FDA standards for implantable cardiac devices under Class III regulatory classification.

• Are there specific models or reference codes associated with this device, and why might that matter for ordering or inventory?

  Yes, the device is tracked using multiple FEI numbers (e.g., 3002807576, 2017865, etc.) and registration numbers (e.g., 2017865, 3005334138) for regulatory and inventory purposes. These identifiers help ensure traceability, compliance with reporting requirements, and accurate ordering of the correct model for surgical implantation.

• Can patients with this device safely undergo MRI procedures, and what considerations should be taken?

  The Prima Unipolar Cardiac Pulse Generator adheres to MRI safety guidelines as outlined in its regulatory submissions, meaning it is designed to be compatible with magnetic resonance imaging when implanted. However, clinicians should follow the manufacturer’s specific MRI safety instructions—such as using approved MRI protocols and avoiding high-field strengths—to minimize risks to the patient during imaging.