Programalith III-3 Model 231 Pulse Generator
by Pacesetter Systems 510(k)
Active
510(k) K850651
Overview
The Programalith III-3 Model 231 Pulse Generator is an Implantable Pacemaker Pulse-Generator (Product Code DXY), designed to regulate cardiac rhythm by delivering electrical impulses to the heart. This device is intended for patients requiring chronic pacing support, providing programmable pacing parameters to address bradycardia or other conduction disorders.
This pulse generator is supplied as a single-use, implantable device and is classified as Class III under FDA regulations, indicating its high-risk, life-sustaining nature. It is regulated under FDA 510(k) clearance K850651 and must be implanted surgically by a qualified healthcare professional. No additional sterility or MRI safety specifications are noted in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850651 | Date1 Apr 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- Withdrawn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 purpose of the Programalith III-3 Model 231 Pulse Generator, and who should use it?
The Programalith III-3 Model 231 Pulse Generator is designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart, specifically for patients with chronic bradycardia or conduction disorders requiring long-term pacing support. It is intended for surgical implantation by qualified healthcare professionals and is not suitable for temporary or external use.
Is the Programalith III-3 Model 231 Pulse Generator intended for reuse, or is it meant to be used only once?
The Programalith III-3 Model 231 Pulse Generator is explicitly supplied as a single-use, implantable device. Once implanted, it is not designed for removal or reuse, and each unit is intended for one patient only.
What regulatory pathway does this device follow, and how was its safety and effectiveness determined?
The Programalith III-3 Model 231 Pulse Generator follows the FDA 510(k) clearance pathway, specifically under Traditional Review with a Substantially Equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee. Its safety and effectiveness were evaluated through a pre-market submission (K850651) filed in 1985, demonstrating compliance with FDA Class III requirements for high-risk, life-sustaining devices.
Are there any special handling or storage requirements for this device before implantation?
While the provided data does not specify sterility assurances beyond its single-use, implantable classification, the device must be handled under sterile conditions prior to surgical implantation, as is standard for all implantable medical devices. Storage should follow manufacturer guidelines (not detailed here) to maintain integrity until use, though no additional storage specifications (e.g., temperature, humidity) are mentioned in the available data.
How is this device categorized in terms of risk, and what does that mean for its use in clinical settings?
The Programalith III-3 Model 231 Pulse Generator is classified as a Class III device under FDA regulations, indicating it is a high-risk, life-sustaining or life-supporting product. This classification means it requires rigorous pre-market review (as evidenced by the 510(k) clearance) and must be implanted only by trained professionals in settings equipped to manage potential complications, such as cardiac surgery centers or electrophysiology labs.