Model 228-02 Thinlith II Pacemaker, Bipo

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K791379 ↗

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 is the primary clinical purpose of the Model 228-02 Thinlith II Pacemaker, Bipolar, and how does its bipolar design benefit patients?

  The Model 228-02 Thinlith II Pacemaker, Bipolar is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients experiencing bradycardia or conduction disorders requiring consistent pacing support. Its bipolar configuration enhances precision in pacing and sensing cardiac signals, which helps improve accuracy in detecting the heart’s natural electrical activity and delivering targeted pacing stimuli.

• Is the Model 228-02 Thinlith II Pacemaker intended for single-use or reusable applications, and how should it be handled in a clinical setting?

  The Model 228-02 Thinlith II Pacemaker is supplied as a single-use implantable device. It is intended for sterile surgical implantation in a clinical setting, meaning it should only be used once per patient and must be handled under aseptic conditions to maintain sterility before implantation.

• What regulatory pathway does the Model 228-02 Thinlith II Pacemaker follow, and how does this affect its use in the U.S.?

  The Model 228-02 Thinlith II Pacemaker received FDA 510(k) clearance (K791379) under the Traditional review pathway, classified as substantially equivalent to a predicate device. This means it adheres to FDA standards for implantable cardiac devices and is authorized for use in the U.S. under Class III regulatory requirements, ensuring compliance with strict safety and performance guidelines for cardiac rhythm management.

• Does the Model 228-02 Thinlith II Pacemaker come in multiple sizes or models, and if so, how would a clinician determine the appropriate fit for a patient?

  The provided data does not specify multiple sizes or models for the Model 228-02 Thinlith II Pacemaker, Bipolar, implying it is likely offered as a single standardized unit. Clinicians would rely on standard sizing guidelines for implantable pacemakers, patient anatomy, and manufacturer recommendations (if applicable) to ensure proper fit and functionality during implantation.

• What storage requirements should be followed for the Model 228-02 Thinlith II Pacemaker before surgical implantation?

  Since the Model 228-02 Thinlith II Pacemaker is a sterile, single-use device intended for surgical implantation, it should be stored in its original packaging until use. The packaging must remain unopened and protected from contamination, moisture, or physical damage. Follow the manufacturer’s specific storage instructions (e.g., temperature ranges) to preserve sterility and functionality until implantation.