đź“‹ FDA Reference
model 439-07 and 439-09 lifeline myocardial lead
Intermedics
Summary: The Lifeline Myocardial Lead is a cardiac device used for pacing the heart. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K880551 ↗
Decision Date
March 7, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline Myocardial Lead, manufactured by Intermedics, was cleared via the FDA 510k pathway on March 7, 1988. It is a Class III device under product code DTB.
What It Is
The Lifeline Myocardial Lead is a specialized lead used in cardiac pacing systems. It is designed to deliver electrical impulses directly to the myocardium, or heart muscle, to maintain an adequate heart rate. This device is crucial for patients with arrhythmias or heart block who require consistent cardiac pacing.
Clinical Applications
This device is commonly used in cardiology, particularly in procedures involving the implantation of pacemakers. It is used in hospital settings, often in cardiac catheterization labs or during open-heart surgery. The typical patient population includes those with bradycardia, heart block, or other conditions requiring pacing support.
Indications for Use
The FDA indications for the Lifeline Myocardial Lead include use in patients who need cardiac pacing due to conditions like bradycardia or heart block. It is intended for those who cannot maintain a stable heart rhythm on their own.
Practical Considerations
The Lifeline Myocardial Lead is available in different sizes to accommodate various patient anatomies. It is compatible with most pacemaker generators. Proper placement and secure attachment to the myocardium are critical for optimal function.
Frequently Asked Questions
What is the Lifeline Myocardial Lead used for?
It is used for cardiac pacing in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and cardiac surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to 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.