MDL-201 Implantable Pacemaker Pulse-Generator
by Pacesetter Systems 510(k)
Active
510(k) K772051
Overview
The MDL-201 is an implantable pacemaker pulse-generator, a Class III medical device designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when natural electrical activity is insufficient. It is intended for patients with bradycardia or other conduction disorders requiring chronic cardiac pacing, providing consistent pacing signals to maintain proper heart function.
This device is supplied sterile and intended for single-use implantation by a qualified healthcare professional in a clinical setting. It is regulated under FDA 510(k) clearance (K772051) and falls under the product code DXY, adhering to the regulatory requirements for implantable cardiac devices. Storage and handling must comply with manufacturer guidelines to ensure sterility and functionality prior to use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK772051 | Date30 Jan 1978 | 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- Withdrawn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
- Full name
- Mdl-201
- 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 types of patients is the MDL-201 intended to treat, and how does it work?
The MDL-201 is designed for patients with bradycardia or conduction disorders requiring chronic cardiac pacing. It functions as an implantable pacemaker pulse-generator, delivering controlled electrical impulses to the heart muscle when the heart’s natural electrical activity is insufficient. This ensures consistent pacing signals to maintain proper heart rhythm and function.
Is the MDL-201 meant for reuse, or is it a single-use device?
The MDL-201 is explicitly intended for single-use implantation only. It is supplied sterile and must be used once by a qualified healthcare professional in a clinical setting. Reuse is not permitted to preserve sterility and functionality.
How should the MDL-201 be stored to maintain its integrity before use?
The device must be stored according to the manufacturer’s guidelines to ensure sterility and functionality. Since it is sterile upon supply, proper storage conditions—such as sealed packaging, controlled temperature, and protection from contamination—are critical before implantation.
What regulatory pathway does the MDL-201 follow, and how does that affect its use?
The MDL-201 is regulated under FDA 510(k) clearance (K772051) and classified as a Class III medical device, indicating it requires stringent oversight due to its life-sustaining nature. Its product code (DXY) aligns with implantable cardiac devices, ensuring compliance with FDA requirements for safety and efficacy in clinical settings.