📋 FDA Reference
Pacing Lead Models Mam 1260 Mam 1290
R.E. Brown
Summary: The pacing lead models MAM 1260 and MAM 1290 by R.E. Brown are used in cardiac pacing systems to deliver electrical impulses to the heart. They are primarily used by cardiologists and electrophysiologists in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K781621 ↗
Decision Date ?
December 8, 1978
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The pacing lead models MAM 1260 and MAM 1290 were cleared by the FDA via the 510k pathway on December 8, 1978. They are manufactured by R.E. Brown and classified as Class III devices.
What It Is
The pacing lead models MAM 1260 and MAM 1290 are components of cardiac pacing systems, designed to deliver electrical impulses from a pacemaker to the heart muscle. These leads are crucial for maintaining heart rhythm in patients with arrhythmias. They are typically inserted transvenously and positioned within the heart chambers.
FDA-Cleared Indications
- Use as a component of a cardiac pacemaker system for patients requiring electrical stimulation of the heart.
- Use in patients with bradycardia or heart block when permanent cardiac pacing is indicated.
Clinical Applications
- Transvenous implantation as part of a permanent pacemaker system.
- Delivery of electrical impulses from a pacemaker generator to the heart muscle.
- Cardiac pacing for patients with clinically significant bradycardia.
- Cardiac pacing for patients with heart block or other conduction disorders requiring pacing.
Practical Considerations
- Confirm that the lead length, connector, and electrical specifications are compatible with the intended pacemaker generator before implantation.
- Lead placement is generally performed under fluoroscopic imaging through venous access, with positioning in the appropriate heart chamber.
- The record does not establish MRI compatibility; MRI should not be assumed safe unless the complete implanted pacing system is specifically labeled as MR conditional.
- Evaluate for patient-specific contraindications to pacemaker implantation, including active infection or inability to tolerate the implantation procedure.
- Lead performance depends on secure positioning, adequate electrical measurements, and ongoing follow-up for sensing, capture, insulation, and lead integrity.
Frequently Asked Questions
What is the pacing lead models MAM 1260 & MAM 1290 used for?
These leads are used to deliver electrical impulses to the heart in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these pacing leads in clinical settings.
What are the FDA-cleared indications?
The leads are indicated for use in patients needing cardiac pacing due to conditions like bradycardia or heart block.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.