Programalith III Model 249 Pulse Generator
by Pacesetter Systems 510(k)
Active
510(k) K851861
Overview
The Programalith III Model 249 Pulse Generator is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It falls under the classification of an Implantable Pacemaker Pulse-Generator, serving as a critical component in treating bradycardia or other cardiac conduction disorders.
This device is intended for surgical implantation and is regulated under FDA 510(k) clearance (K851861) with a decision of Substantially Equivalent. Supplied sterile and intended for single-use implantation, it adheres to regulatory standards outlined in 21 CFR 870.3610. The device is classified as Class III, requiring premarket approval, and is manufactured by Pacesetter Systems.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK851861 | Date16 May 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXY
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pacesetter Systems
Questions
What is the primary clinical purpose of the Programalith III Model 249 Pulse Generator, and how does it achieve this?
The Programalith III Model 249 Pulse Generator is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically addressing bradycardia or other cardiac conduction disorders. It functions as an implantable pacemaker pulse-generator, providing consistent pacing signals to maintain a normal heart rate when the heart’s natural conduction system is impaired.
Is the Programalith III Model 249 Pulse Generator intended for reuse, or is it meant to be implanted as a single-use device?
The Programalith III Model 249 Pulse Generator is supplied sterile and explicitly intended for single-use implantation. This aligns with its classification as a Class III medical device under 21 CFR 870.3610, where sterility and one-time use are standard for implanted cardiac devices to ensure patient safety and prevent infection.
What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?
The Programalith III Model 249 Pulse Generator received FDA clearance through a 510(k) premarket notification process (K851861) with a decision of *Substantially Equivalent* to a predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as an Implantable Pacemaker Pulse-Generator under FDA’s regulatory framework for Class III devices.
How is the device classified under FDA regulations, and what does this classification imply for its use?
The Programalith III Model 249 Pulse Generator is classified as a Class III device under FDA regulations, which requires premarket approval (PMA) due to its role in sustaining life or supporting life-sustaining activities. This classification underscores the device’s critical function in treating life-threatening cardiac conditions like bradycardia, necessitating rigorous scrutiny to ensure safety and efficacy.
What are the key specifications or identifiers associated with this device’s regulatory filing, such as the product code or registration numbers?
The device’s regulatory filing includes the product code DXY and multiple registration numbers (e.g., 2017865, 3005334138, etc.), which are tied to its classification as an Implantable Pacemaker Pulse-Generator. These identifiers are used for tracking submissions, manufacturing compliance, and inventory management within the FDA’s OpenFDA database and related systems.