Implantable Pulse Generator Pacemakers

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K791568 ↗

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

• 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

• Poly Flex Implantable Pacing Lead

  Class III

  FDA 510(k) K802294 Active Cleared 3 Apr 1985

See all devices from Intermedics, Inc. →

• What types of heart conditions is this implantable pulse generator pacemaker designed to address, and how does it work?

  This device is specifically designed to manage bradycardia (slow heart rhythms) and other cardiac conduction disorders that require chronic pacing support. It works by delivering precise electrical impulses to the heart muscle through leads placed in the heart chambers, helping to regulate abnormal heart rhythms and maintain a consistent heartbeat.

• How is this pacemaker supplied, and is it intended for single-use or reusable applications?

  The device is supplied sterile and is intended for single-use implantation. It requires surgical placement under the skin, typically near the collarbone, and is connected to leads within the heart. Due to its sterile packaging and implantation procedure, reuse is not recommended or supported.

• What regulatory pathway does this device follow, and how does its classification impact its use?

  This pacemaker is classified as a Class III medical device under FDA 510(k) clearance (K791568) and falls under the product code DXY for implantable pacemaker pulse-generators. Its Substantially Equivalent (SESE) decision classification means it meets FDA standards for safety and effectiveness comparable to legally marketed devices, ensuring it adheres to strict cardiovascular device regulations (CFR 870.3610).

• Are there multiple models or sizes available for this pacemaker, and how would a clinician determine the appropriate fit for a patient?

  While the provided data does not specify exact model variations or sizing details, the device is designed to accommodate a range of patient anatomies through surgical customization. Clinicians typically select the appropriate model based on factors like patient size, lead placement requirements, and specific pacing needs (e.g., single-chamber, dual-chamber). The manufacturer’s documentation would provide guidance on compatibility and programming options for individual cases.

• How should this device be stored before implantation, and are there any special handling requirements?

  Since the device is supplied sterile, it must be stored in its original packaging until use to maintain sterility. Storage conditions typically include protection from extreme temperatures, moisture, and physical damage. The manufacturer’s instructions would detail exact storage guidelines, such as refrigeration or room-temperature storage, to ensure the device remains functional and safe for implantation.