Bifocal 2 8200 Series (A, B, C, D)

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

510(k) Number

K800379 ↗

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 patients is the Bifocal 2 8200 Series designed to treat, and how does it work?

  The Bifocal 2 8200 Series is intended for patients with bradycardia or conduction system disorders, conditions where the heart beats too slowly or fails to coordinate contractions properly. This implantable pacemaker pulse-generator delivers timed electrical impulses to stimulate the heart’s chambers, ensuring proper pacing and maintaining a regular heart rhythm.

• Is the Bifocal 2 8200 Series meant for single-use or can it be reused after implantation?

  The Bifocal 2 8200 Series is explicitly designed for single-use only. Once implanted, it is not intended to be removed or reused, aligning with standard practices for implantable pacemaker pulse-generators to ensure patient safety and device reliability.

• What model variants are available in the Bifocal 2 8200 Series, and how do they differ?

  The Bifocal 2 8200 Series includes four model variants: A, B, C, and D. While the exact differences between these models are not specified in the data, the variants are likely tailored to accommodate varying patient needs, such as pacing requirements, battery life, or lead configurations, ensuring flexibility for clinical use.

• How is the Bifocal 2 8200 Series supplied, and is it sterile?

  The Bifocal 2 8200 Series is supplied sterile, which is standard for implantable devices to prevent infection during surgical implantation. This ensures the device is ready for immediate use in the operating room without additional sterilization steps.

• What regulatory pathway was followed for the FDA clearance of the Bifocal 2 8200 Series, and what does this mean for its safety?

  The Bifocal 2 8200 Series underwent a traditional 510(k) clearance process through the FDA, with a decision described as 'Substantially Equivalent' to a predicate device. This pathway ensures the device meets safety and performance standards for implantable pacemaker pulse-generators, as overseen by the Cardiovascular (CV) Advisory Committee. The clearance number is K800379.