TDL-100 B Implantable Pacemaker Pulse-Generator
by Pacesetter Systems 510(k)
Active
510(k) K772050
Overview
The TDL-100 B is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. It is intended for patients with bradycardia or other conduction disorders requiring chronic cardiac pacing, providing programmable pacing rates and modes to support sustained cardiac function.
This device is supplied sterile and intended for single-use implantation, though it may be designed for long-term use within the body. It is regulated under FDA 510(k) clearance (K772050) and falls under the Cardiovascular advisory committee classification, adhering to 21 CFR 870.3610 for pacemaker pulse-generators. Storage and handling must comply with sterile medical device protocols to ensure reliability and patient safety.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK772050 | 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- Withdrawn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
- Tdl-100 B
- 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 heart conditions is the TDL-100 B pacemaker designed to treat, and how does it work?
The TDL-100 B is designed to address bradycardia (slow heart rate) and other conduction disorders requiring chronic cardiac pacing. It works by delivering programmable electrical impulses to the heart muscle, regulating abnormal rhythms and maintaining sustained cardiac function. The device adjusts pacing rates and modes to support consistent heart activity for patients who rely on long-term pacing.
Is the TDL-100 B intended for single-use or reusable implantation, and how should it be handled?
The TDL-100 B is supplied sterile and intended for single-use implantation, though it is designed for long-term use within the body once implanted. Due to its sterile packaging, proper sterile medical device protocols must be followed during handling and preparation to ensure reliability and patient safety.
What regulatory pathway does the TDL-100 B follow, and which advisory committee oversees its classification?
The TDL-100 B is classified as a Class III medical device under FDA 510(k) clearance (K772050) and falls under the Cardiovascular advisory committee (CV). It adheres to 21 CFR 870.3610, which governs pacemaker pulse-generators, ensuring compliance with strict regulatory standards for safety and efficacy.
Are there multiple models or sizes available for the TDL-100 B, or is it a single-unit device?
The provided data does not specify multiple models or sizes for the TDL-100 B, implying it is likely a single-unit design intended for general use in bradycardia and conduction disorder cases. If specific sizing or model variations are required, additional documentation or manufacturer inquiries would be necessary.