Implantable Pulse Generator Pacemaker

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K791417 ↗

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 types of heart conditions is this pacemaker designed to treat, and how does it work?

  This Implantable Pulse Generator Pacemaker is specifically designed for patients with bradycardia or conduction disorders that require chronic cardiac pacing. It regulates heart rhythm by delivering precise electrical impulses to the heart muscle, ensuring consistent pacing to maintain normal heart function. The device is implanted subcutaneously and is intended for long-term use in patients whose natural heart rate is too slow or irregular.

• Is this device single-use, and if so, what does that mean for storage and handling?

  Yes, this pacemaker is supplied sterile for single-use only. This means each unit is intended for one patient and must remain unopened until implantation. Storage and handling must follow strict sterile medical device protocols to ensure sterility is maintained until use, preventing contamination or damage to the device.

• Are there multiple models available, and how can I determine which one is compatible with my patient’s needs?

  Yes, this pacemaker is available in multiple model variants, as indicated by the registration records. While the exact specifications of each model are not detailed here, compatibility should be confirmed with Intermedics, Inc. based on your patient’s clinical requirements, such as pacing needs, MRI compatibility (under specific conditions), and other individualized factors. Always consult the manufacturer’s guidelines or a specialist for model selection.

• Can this device be used in patients who require MRI scans, and what precautions should be taken?

  This pacemaker is compatible with MRI environments under specific conditions, though the exact parameters are not detailed in the provided data. If MRI is required, strict adherence to the manufacturer’s guidelines is essential to ensure patient safety. Always verify MRI compatibility with Intermedics, Inc. and follow their recommended protocols to avoid risks such as device malfunction or interference.

• How was this device’s regulatory pathway determined, and what does the FDA 510(k) clearance mean for its use?

  This pacemaker was cleared through the FDA’s 510(k) pathway, which determines that it is *substantially equivalent* to a legally marketed device already on the market. The clearance (K791417) was granted by the Cardiovascular (CV) Advisory Committee after reviewing its design, performance, and safety. This means it meets FDA standards for safety and effectiveness as a Class III medical device, but it does not imply any specific clinical indication—only that it follows regulatory requirements for implantation in patients with bradycardia or conduction disorders.