Lifeline Bipolar Pacing Lead Mod. 466-01
by Intermedics, Inc. 510(k)
Active
510(k) K781498
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781498 | Date1 Feb 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- DTB
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Lifeline Bipolar Pacing Lead Mod. 466-01 is a permanent pacemaker electrode, designed to deliver electrical impulses from an implanted pacemaker to the heart. It facilitates cardiac pacing by ensuring proper heart rhythm through bipolar stimulation, reducing the risk of arrhythmias in patients requiring chronic pacing support.
This device is intended for single-use implantation and is classified under FDA regulation 870.3680. It is supplied sterile and requires surgical implantation by a healthcare professional. The lead is regulated under the DTB product code and holds a 510(k) clearance (K781498) with a decision of Substantially Equivalent, granted in 1979. No additional MRI safety or reusable specifications are noted in the available data.
Other devices from Intermedics, Inc.
Questions
AI-generated answers, 18 Sep 2026
Is this pacing lead designed for reuse or is it intended for single-use only after implantation?
The Lifeline Bipolar Pacing Lead Mod. 466-01 is explicitly designed for single-use implantation only. The device is supplied sterile and must be implanted surgically by a healthcare professional, with no indication or approval for reuse.
What types of storage conditions should be followed for this device before implantation?
While the provided data does not specify exact storage conditions, the lead is supplied sterile and intended for surgical implantation. Standard sterile storage practices—such as protecting from moisture, extreme temperatures, and physical damage—should be followed to maintain integrity until use.
Does this lead come in multiple sizes or models, and if so, how would I identify the correct one for a patient?
The data only references one model (Mod. 466-01) of the Lifeline Bipolar Pacing Lead. Selection should be based on clinical assessment and compatibility with the patient’s anatomy and the implanted pacemaker system, as no additional sizing variations are mentioned.
How was the regulatory pathway for this device determined, and what does the ‘Substantially Equivalent’ decision mean in practice?
The Lifeline Bipolar Pacing Lead Mod. 466-01 received a 510(k) clearance (K781498) under the Traditional review pathway, determined by the FDA’s Cardiovascular (CV) Advisory Committee. The ‘Substantially Equivalent’ decision means the device was found to have the same intended purpose, technological characteristics, and performance as a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness without requiring new clinical trials.