Pacemaker Programmer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K790220 ↗

FDA Product Code

KRG

Device Class

Class III

Regulation

21 CFR Part 870.3700

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 is the primary purpose of the Pacemaker Programmer and how does it work without surgery?

  The Pacemaker Programmer is designed to noninvasively adjust the electrical settings of implanted pacemakers, such as pacing rate, output amplitude, and timing intervals. It achieves this through wireless or external programming interfaces, allowing healthcare professionals to fine-tune cardiac rhythm management without requiring surgical access to the implanted device. This capability ensures optimal pacing therapy for patients with bradycardia or other cardiac conduction disorders.

• Is the Pacemaker Programmer intended for single-use or repeated use in clinical settings, and what storage requirements apply?

  The Pacemaker Programmer is supplied as a reusable instrument, meaning it is designed for multiple uses in clinical settings like cardiac electrophysiology labs or hospital wards. Since it is non-sterile, no special sterilization procedures are required. Standard environmental controls—such as protection from extreme temperatures, moisture, and physical damage—are sufficient for storage and maintenance.

• What regulatory pathway was followed for FDA clearance of this device, and what medical specialty does it fall under?

  The Pacemaker Programmer received FDA clearance through a Traditional 510(k) pathway, classified under product code KRG and regulatory category 870.3700. It is categorized under the Cardiovascular medical specialty, indicating its use in managing cardiac rhythm disorders. The clearance was granted in 1979 and remains valid under the current regulatory framework.

• Are there any special considerations for using this device in environments with MRI equipment?

  The device data does not specify any MRI safety certifications or restrictions, meaning it may not be explicitly labeled as MRI-compatible or safe for use in MRI environments. Clinicians should verify compatibility with the specific MRI system and follow manufacturer guidelines to avoid potential interference or safety risks to patients or the device itself.