Programalith III Pulse Generator
by Pacesetter Systems 510(k)
Active
510(k) K861140
Overview
The Programalith III Pulse Generator is an Implantable Pacemaker Pulse-Generator (product code DXY), designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients requiring permanent pacing due to bradycardia or other conduction disorders, providing programmable pacing parameters to maintain normal heart function.
This device is implanted subcutaneously and is intended for single-use, though it may be serviced or reprogrammed externally via specialized equipment. It is classified under FDA regulation number 870.3610 and holds a FDA 510(k) clearance (K861140) for substantial equivalence. Supplied sterile and intended for use in clinical settings, it adheres to Class III regulatory requirements for implantable cardiac devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861140 | Date2 May 1986 | 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- Withdrawn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 Pulse Generator, and how does it achieve this?
The Programalith III Pulse Generator is designed to regulate cardiac rhythm in patients with bradycardia or conduction disorders by delivering controlled electrical impulses to the heart. It achieves this through programmable pacing parameters, ensuring consistent and appropriate heart function after subcutaneous implantation.
Is the Programalith III Pulse Generator intended for single-use, or can it be reused after servicing?
The Programalith III Pulse Generator is intended for single-use implantation, though it can be externally serviced or reprogrammed using specialized equipment. This allows clinicians to adjust pacing parameters without replacing the entire device.
How is the Programalith III Pulse Generator supplied, and what regulatory standards ensure its safety for clinical use?
The Programalith III Pulse Generator is supplied sterile and is intended exclusively for clinical settings. Its compliance with Class III regulatory requirements for implantable cardiac devices, along with FDA 510(k) clearance (K861140), ensures it meets stringent safety and performance standards for implantation.
What types of patients is this device intended for, and how is it implanted?
This device is intended for patients requiring permanent pacing due to bradycardia or conduction disorders. It is implanted subcutaneously, meaning it is surgically placed beneath the skin, typically near the chest area, to deliver pacing impulses directly to the heart.