Pacing Lead Models MDM 1060, MDM 1090

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781620 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Stilith Cardiac Pacemakers-M 60 & 120

  Class III

  FDA 510(k) K780781 Active Cleared 27 Jul 1978

• Pacing Lead Models MAM 1260 MAM 1290

  Class III

  FDA 510(k) K781621 Active Cleared 8 Dec 1978

• Pacing Lead Model Bus 860, Bus 890

  Class III

  FDA 510(k) K781624 Active Cleared 21 Dec 1978

• Pacing Lead Adapter, Acv 14, Acv 23

  Class II

  FDA 510(k) K781626 Active Cleared 8 Dec 1978

• Pacing Lead Model MVM 860, MVM 890

  Class III

  FDA 510(k) K781625 Active Cleared 8 Dec 1978

• Pacing Models Mum 860, Mum 890

  Class III

  FDA 510(k) K781623 Active Cleared 8 Dec 1978

See all devices from R.E. Brown Co., Inc. →

• Are these pacing leads intended for reuse or are they single-use only, and how should they be handled before implantation?

  These leads (MDM 1060 and MDM 1090) are explicitly designed for single-use implantation only. They are supplied sterile in their packaging, so they must be handled using aseptic techniques to maintain sterility before use. This aligns with standard cardiovascular surgical protocols to prevent infection and ensure patient safety.

• What types of cardiac rhythm disorders are these leads approved to treat, and how do they function?

  These leads are permanent pacemaker electrodes intended to deliver electrical impulses to the heart for treating bradycardia or other cardiac rhythm disorders. They are implanted within the cardiovascular system to stimulate the heart muscle, ensuring proper pacing functionality for patients requiring long-term cardiac support.

• How are these leads distributed, and what storage or handling precautions should be taken?

  The leads are supplied in sterile packaging and must be stored according to standard aseptic protocols. Since they are intended for direct surgical use, they should be kept in a clean, dry environment away from contamination until ready for implantation. The sterile barrier must remain intact until use.

• What regulatory pathway was followed for FDA clearance, and which advisory committee was involved?

  These leads were cleared through the FDA 510(k) pathway under the classification of Device Class III (regulation number 870.3680). The submission was reviewed by the Cardiovascular (CV) Advisory Committee, and the decision was made under the Traditional 510(k) Review process, with a clearance number of K781620.