Programalith III 240 Pulse Generator
by Pacesetter Systems 510(k)
Active
510(k) K850464
Overview
The Programalith III 240 Pulse Generator is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients requiring pacing support due to bradycardia or other conduction disorders, ensuring consistent and reliable cardiac output.
This device is supplied as a reusable, implantable system and is regulated under FDA 510(k) clearance (K850464) with a traditional review process. It falls under the Cardiovascular specialty and is classified under regulation number 870.3610, adhering to strict safety and performance standards for high-risk, life-sustaining devices. No MRI safety or sterility specifications are explicitly stated in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850464 | Date15 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- Withdrawn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 purpose of the Programalith III 240 Pulse Generator, and who is it designed for?
The Programalith III 240 Pulse Generator is an implantable pacemaker designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients with bradycardia or conduction disorders who require pacing support to maintain consistent and reliable cardiac output.
Is the Programalith III 240 Pulse Generator intended for single-use or reusable applications?
The Programalith III 240 Pulse Generator is explicitly described as a reusable, implantable system. It is not intended for single-use and is designed for long-term implantation in patients.
How is the regulatory status of this device determined, and what type of review process was used?
The Programalith III 240 Pulse Generator is classified as a Class III medical device and was granted FDA clearance through a 510(k) submission (K850464). It underwent a traditional review process by the FDA’s Cardiovascular advisory committee, ensuring compliance with strict safety and performance standards for high-risk, life-sustaining devices.
What are the key specifications or models associated with this device, and how can I verify its authenticity?
The Programalith III 240 Pulse Generator is associated with multiple FDA registration numbers (e.g., 2017865, 3005334138) and FEI numbers (e.g., 3002807576). These identifiers can be used to verify authenticity or traceability through the FDA’s OpenFDA database or registration records. The device falls under product code DXY and regulation number 870.3610.
Does this device have any special handling requirements, such as sterility or storage instructions?
The provided data does not explicitly mention sterility specifications or special storage instructions for the Programalith III 240 Pulse Generator. However, as an implantable device, it should be handled under sterile conditions during implantation and stored according to manufacturer guidelines to maintain integrity until use. Always refer to the manufacturer’s instructions for proper storage and handling.