Programalith(Tm) Model 223 Pulse Generator & 398 P

No FDA recalls on record, checked 22 Oct 2026.

Generic Name

Implantable pulse generator, pacemaker (non-CRT)

PMA Number

P820023 ↗

FDA Product Code

LWP

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

PMA Supplement

S003

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• What is the primary purpose of the Programalith Model 223 Pulse Generator & 398P, and how does it function in a patient’s body?

  The Programalith Model 223 Pulse Generator & 398P is designed as an implantable pacemaker (non-CRT) to regulate abnormal heart rhythms by delivering timed electrical impulses. It is intended for patients with bradycardia or conduction disorders, ensuring the heart beats at a consistent, appropriate rate to maintain proper cardiac function.

• Is this device intended for single-use or can it be reused after implantation?

  The Programalith Model 223 Pulse Generator & 398P is explicitly described as a **reusable component** within a pacemaker system. It is not a disposable device and is intended to remain implanted long-term, with potential adjustments or replacements as clinically indicated.

• What regulatory pathway was followed for this device’s approval, and when was it finalized?

  This device was approved through the FDA’s **Premarket Approval (PMA)** process, with the PMA number **P820023**. The decision to approve was made on **November 21, 1983**, following a review by the FDA’s Cardiovascular (CV) advisory committee. The original application was filed on **August 9, 1983**.

• Are there different model configurations available for this pulse generator, and what do the model numbers (223 and 398P) signify?

  Yes, the **Programalith Model 223** and **398P** represent specific configurations within the same pacemaker system. While the exact differences between these models are not detailed in the data, the **223** is the primary pulse generator designation, and the **398P** appears as a related component (likely a lead or pacing module) in the system’s assembly. These identifiers help clinicians and technicians select the correct components for implantation.