Model 221 Programalith Pulse Generator
by Pacesetter Systems 510(k)
Active
510(k) K790873
Overview
The Model 221 Programalith Pulse Generator is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is classified as a Class III device under FDA regulation 870.3610, intended for patients requiring chronic cardiac pacing support.
This device is supplied sterile and intended for single-use implantation, though its long-term functionality depends on proper programming and maintenance. It is regulated under FDA 510(k) clearance K790873, with a decision of Substantially Equivalent (SESE) issued in 1979. No MRI safety information or reusable specifications are provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790873 | Date20 Sep 1979 | 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- Withdrawn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 Model 221 Programalith Pulse Generator and who would benefit from it?
The Model 221 Programalith Pulse Generator is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, providing chronic cardiac pacing support. It is intended for patients who require long-term pacing due to conditions like bradycardia or other cardiac conduction disorders. The device is specifically classified as an implantable pacemaker pulse-generator under FDA regulation 870.3610, making it suitable for clinicians managing patients with chronic pacing needs.
Is the Model 221 Pulse Generator meant for single-use or can it be reused after implantation?
The Model 221 Pulse Generator is supplied sterile and explicitly intended for single-use implantation. While it is designed for long-term functionality once implanted, the manufacturer does not specify reusable specifications, and the device should not be reused after initial use. Proper programming and maintenance are required to ensure its continued functionality post-implantation.
How is the Model 221 Pulse Generator regulated by the FDA, and what does that mean for clinicians?
The Model 221 Pulse Generator is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K790873, and was determined to be Substantially Equivalent (SESE) in 1979. This classification means the device meets FDA standards for safety and effectiveness as an implantable pacemaker pulse-generator, ensuring clinicians can rely on its regulatory compliance for chronic cardiac pacing applications. The decision was reviewed by the Cardiovascular (CV) Advisory Committee.
What storage or handling considerations should be taken into account for the Model 221 Pulse Generator before implantation?
Since the Model 221 Pulse Generator is supplied sterile, it must be handled in a manner that maintains sterility until implantation. As it is intended for single-use, it should not be exposed to contamination or improper storage conditions. Clinicians should follow standard sterile packaging protocols for implantable devices to ensure patient safety during surgical procedures.