AFP Pulse Generator
by Pacesetter Systems 510(k)
Active
510(k) K823559
Overview
The AFP Pulse Generator is an Implantable Pacemaker Pulse-Generator, designed to deliver electrical impulses to regulate heart rhythm in patients with bradycardia or conduction disorders. It serves as the power source and control unit for implantable pacemaker systems, ensuring consistent pacing therapy through programmable parameters.
This device is intended for single-use implantation and is classified under FDA regulation 870.3610 as a Class III medical device, with FDA 510(k) clearance (K823559) under the Traditional 510(k) Review Process. Supplied sterile and intended for surgical implantation, it requires proper handling and storage as per manufacturer guidelines to maintain sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823559 | Date18 Feb 1983 | 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- Withdrawn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 AFP Pulse Generator in a patient’s treatment plan?
The AFP Pulse Generator is designed to regulate heart rhythm by delivering electrical impulses to treat bradycardia (slow heart rate) or conduction disorders. It acts as the power source and control unit for an implantable pacemaker system, ensuring consistent pacing therapy through programmable settings.
Is the AFP Pulse Generator intended for reuse after implantation, or is it meant to be used only once?
The AFP Pulse Generator is explicitly intended for single-use implantation. It is supplied sterile and is not designed for removal or reuse, so proper handling and sterile storage are critical before and during the procedure.
How should the AFP Pulse Generator be stored to maintain its sterility and functionality?
The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is supplied sterile and intended for surgical implantation, it should be kept in its original packaging, protected from contamination, and used within the specified expiration date.
What regulatory pathway was followed for FDA clearance of this device, and what classification does it fall under?
The AFP Pulse Generator received FDA clearance through the Traditional 510(k) Review Process under the Cardiovascular (CV) Advisory Committee. It is classified as a Class III medical device (FDA regulation 870.3610) due to its role in life-sustaining or life-supporting functions, requiring strict regulatory oversight.