Unifocal 3-2 Models Unipolar & Bipolar

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K792232 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Apc Implantabel Pacing Lead, Model 3264

  Class III

  FDA 510(k) K810399 Active Cleared 15 May 1981

• APC Implantable Pacing Lead, Tined #3262

  Class III

  FDA 510(k) K810396 Active Cleared 15 May 1981

• Unifocal 1 Unipolar Demand R Wave

  Class III

  FDA 510(k) K791955 Active Cleared 27 Nov 1979

• APC Implantable Pacing Lead-Flange #3260

  Class III

  FDA 510(k) K810397 Active Cleared 15 May 1981

• External Pulse Generator EV4542

  Class II

  FDA 510(k) K821791 Active Cleared 6 Jul 1982

• Unifocal 2-UNIPOLAR & Bipolar

  Class III

  FDA 510(k) K792199 Active Cleared 27 Nov 1979

See all devices from American Pacemaker Corp. →

• What types of pacing configurations does the Unifocal 3-2 support, and how might a clinician choose between them?

  The Unifocal 3-2 offers both unipolar and bipolar pacing configurations, designed for single-chamber cardiac stimulation. The choice depends on clinical needs and patient anatomy. Unipolar pacing delivers current through a single electrode and the patient’s body, while bipolar pacing uses two electrodes, which can reduce muscle stimulation and improve pacing thresholds. Clinicians may select based on factors like lead placement, patient response, and minimizing discomfort or interference.

• Is this device intended for reuse, and what are the implications for clinical workflows?

  The Unifocal 3-2 is explicitly described as a reusable implantable pulse-generator, not a single-use device. This means it is intended to be surgically implanted once and remain in the patient long-term, requiring no replacement for routine use. However, it is non-sterile as supplied, so it must be sterilized by the healthcare facility before implantation—a critical step in clinical workflows to ensure patient safety.

• What regulatory pathway was followed for this device, and how does that affect its use in clinical settings?

  The Unifocal 3-2 was cleared via the FDA’s 510(k) pathway under Traditional Review, with a decision of *Substantially Equivalent* (SESE) by the Cardiovascular (CV) Advisory Committee. This classification under FDA Device Class III and regulation 21 CFR 870.3610 indicates it is intended for high-risk medical use, requiring implantation only in controlled settings like hospitals or specialized cardiac care facilities. The clearance does not specify MRI safety, so clinicians must follow strict protocols if MRI exposure is necessary.

• Are there multiple models or variations of this device, and if so, how do they differ?

  The Unifocal 3-2 comes in two primary models: unipolar and bipolar. The distinction lies in their pacing circuitry—unipolar uses a single electrode pathway, while bipolar uses two electrodes to deliver the pacing impulse. Both are designed for single-chamber pacing (e.g., right atrium or ventricle) and share the same core function of regulating bradycardia or conduction disorders. No additional size or programming variations are mentioned in the data.