Implantable Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K834096 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

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• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary clinical purpose of this Implantable Pulse Generator and how does it work?

  This device is designed to regulate abnormal heart rhythms by delivering electrical impulses to stimulate the heart muscle, ensuring proper cardiac function in patients with bradycardia or conduction disorders. It functions as an implantable pacemaker pulse-generator, providing consistent pacing signals to maintain a healthy heart rate when the natural conduction system fails.

• Is this device intended for reuse or is it meant to be used only once after implantation?

  The Implantable Pulse Generator is supplied sterile for single-use only. Once implanted, it is not designed for removal or reuse, adhering to standard sterile medical device protocols for implantable electronics.

• How should this device be stored before use, and what precautions should be taken?

  Since it is sterile and single-use, storage must follow strict sterile medical device protocols to maintain integrity. It should be kept in its original packaging, protected from contamination, moisture, and physical damage until immediate preoperative use. Avoid exposure to extreme temperatures or direct sunlight.

• What regulatory pathway was followed for FDA clearance, and what does ‘Substantially Equivalent’ mean in this context?

  This device received FDA 510(k) clearance under the Traditional Review pathway, with a decision labeled *Substantially Equivalent (SESE)*. This means the FDA determined it has the same intended use and technological characteristics as a legally marketed predicate device, ensuring it meets safety and effectiveness standards without requiring new clinical trials.

• Can this device be used in patients who require MRI scans, and what are the manufacturer’s recommendations?

  The Implantable Pulse Generator is MRI-unspecified, meaning its compatibility with MRI procedures is not explicitly defined by the manufacturer. To avoid interference with cardiac pacing or potential harm, strict adherence to manufacturer instructions is required—typically, this includes avoiding MRI scans unless under controlled conditions with specialized protocols or equipment.