Pacing Lead Models MAM 1260 MAM 1290

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781621 ↗

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 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 Models MDM 1060, MDM 1090

  Class III

  FDA 510(k) K781620 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 strictly single-use devices despite the manufacturer’s guidelines allowing reuse?

  These leads are sterile at time of supply and labeled as intended for single-use implantation, though the manufacturer does acknowledge they may be reused per their guidelines. The FDA 510(k) clearance and regulatory classification (Class III) do not override the manufacturer’s stated single-use intent, so clinical practice should align with institutional policies and infection control protocols.

• What are the key differences between the MAM 1260 and MAM 1290 models, and how might a clinician choose between them?

  The provided data does not specify technical differences between the MAM 1260 and MAM 1290 models beyond both being permanent pacing leads for transvenous use. Selection would typically depend on clinical factors like lead design (e.g., coil configuration, tip electrode type), patient anatomy, or procedural requirements—not on regulatory distinctions. Consult the manufacturer’s technical documentation or product brochure for detailed specifications.

• How should these leads be stored to maintain sterility and functionality before implantation?

  Since these leads are sterile upon packaging, they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contamination. The manufacturer’s instructions (not provided here) would detail any specific storage conditions, but standard practices for sterile medical devices apply.

• Are there any MRI safety considerations for patients with these pacing leads implanted?

  Yes, these leads are designed with MRI safety in mind, though the specific MRI compatibility details (e.g., maximum safe field strength, sequence restrictions) are not listed here. Patients should undergo MRI only under strict protocols outlined in the device’s labeling or manufacturer’s MRI safety guidance to prevent lead displacement or damage. Always verify compatibility with the implanted system.

• What regulatory pathway was used for FDA clearance, and does this affect how the device is classified or used?

  The MAM 1260 and MAM 1290 were cleared via the FDA 510(k) Traditional pathway and are classified as Class III devices under 21 CFR 870.3680. This classification reflects their role in life-supporting or sustaining functions (permanent pacing), but the pathway itself does not alter clinical use—only that the device met FDA standards for safety and effectiveness. The product code DTB indicates they fall under the ‘Transvenous Cardiac Pacemaker Electrodes’ category.