Pacing Lead Model MVM 860, MVM 890
by R.E. Brown Co., Inc. 510(k)
Active
510(k) K781625
Overview
The Pacing Lead Model MVM 860, MVM 890 is a Permanent Pacemaker Electrode, designed to deliver electrical impulses to the heart for the treatment of cardiac rhythm disorders. These leads are implanted within the cardiovascular system to stimulate the heart muscle and maintain proper pacing, ensuring regular and effective heart function in patients requiring pacemaker therapy.
These leads are intended for single-use implantation in clinical settings and are classified under FDA Product Code DTB as Class 3 devices. Supplied sterile and intended for use in cardiac electrophysiology procedures, they require proper handling and storage as per manufacturer guidelines. The device received FDA 510(k) clearance under the Traditional pathway in 1978, with a decision classification of Substantially Equivalent to predicate devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781625 | Date8 Dec 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- Withdrawn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
- 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
Other devices from R.E. Brown Co., Inc.
Questions
Are these pacing leads designed for reuse in multiple patients, or are they intended for single-use only?
These leads (MVM 860 and MVM 890) are explicitly intended for single-use implantation in clinical settings. The manufacturer’s description and FDA classification (Class 3, DTB) emphasize sterile supply for cardiac electrophysiology procedures, which aligns with single-patient use to ensure patient safety and sterility.
What storage conditions should be followed for these leads to maintain their sterility and functionality?
The leads are supplied sterile, so they must be stored according to the manufacturer’s guidelines to preserve sterility and integrity. While specific conditions aren’t detailed here, typical best practices for sterile medical devices include keeping them in their original packaging, away from direct sunlight or extreme temperatures, and protecting them from physical damage until use.
How do I determine which model (MVM 860 or MVM 890) is appropriate for my patient’s procedure?
The question of model selection depends on clinical factors like lead placement requirements (e.g., atrial vs. ventricular pacing) and patient anatomy, which aren’t specified in the provided data. However, both models are permanent pacemaker electrodes designed for cardiac rhythm disorders, so compatibility would depend on the specific pacing needs and the surgeon’s discretion. Consulting the manufacturer’s technical documentation or a cardiologist is recommended for precise model selection.
What is the regulatory pathway and approval status for these leads, and when were they cleared by the FDA?
These leads received FDA 510(k) clearance under the Traditional pathway in 1978 (K781625) and are classified as Substantially Equivalent (SESE) to predicate devices. The clearance was filed under the Cardiovascular (CV) advisory committee and falls under FDA Product Code DTB, confirming their status as Class 3 devices for permanent pacemaker electrode use.