Edwards Pacemaker 30 Unipolar Generator

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

510(k) Number

K791751 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Micropulse 26U Pulse Generator

  Class III

  FDA 510(k) K771987 Active Cleared 2 Nov 1977

• Micropulse 22S Pacemaker

  Class III

  FDA 510(k) K780780 Active Cleared 30 Jun 1978

• Prolith 23S Pacemaker

  Class III

  FDA 510(k) K781042 Active Cleared 27 Jul 1978

• Generator, Pulse, Cardiac 2LU

  Class III

  FDA 510(k) K770657 Active Cleared 26 Apr 1977

• Micropulse 22U

  Class III

  FDA 510(k) K780091 Active Cleared 30 Jan 1978

• Analyzer, Pacer System, Psa-5

  Class II

  FDA 510(k) K781144 Active Cleared 23 Aug 1978

See all devices from Edwards Pacemaker Systems →

• Is this pacemaker designed for single-use or can it be reused after implantation?

  This device is explicitly described as a reusable, implantable component, meaning it is intended to be surgically implanted and remain in the patient’s body long-term. It is not a single-use device, and its design aligns with standard implantable cardiac devices that require sterile surgical protocols for initial placement but are not meant to be removed or reused externally.

• What types of patients is this pacemaker intended to support based on its clinical purpose?

  The device is designed for patients with bradycardia or conduction disorders that require consistent pacing stimulation. It delivers electrical impulses to regulate heart rhythm, making it suitable for individuals whose natural heart rate is too slow or irregular due to these conditions.

• Are there any special storage or handling requirements for this pacemaker before implantation?

  Yes, since it is an implantable device, storage and handling must follow sterile surgical protocols—standard practices for cardiac implantables to prevent contamination. This ensures safety and compliance with medical device regulations before surgical use.

• How is this pacemaker regulated in the U.S., and what does its classification mean for clinicians?

  This device is classified as a Class III medical device under FDA regulation 870.3610 and was granted 510(k) clearance (K791751) as substantially equivalent to prior-generation pacemakers. This classification means it undergoes rigorous review for safety and effectiveness, and clinicians can rely on its compliance with FDA standards for cardiovascular use.