đź“‹ FDA Reference
model 486-03 poly flex implantable pacing lead
Intermedics
Summary: The Model 486-03 Poly Flex Implantable Pacing Lead is a cardiac pacing lead used in patients requiring cardiac pacing. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K853411 ↗
Decision Date
October 1, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 486-03 Poly Flex Implantable Pacing Lead was cleared through the FDA 510(k) pathway on October 1, 1985. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Model 486-03 Poly Flex Implantable Pacing Lead is a flexible lead designed for implantation in patients who require cardiac pacing. It connects the heart to an external pacemaker, facilitating electrical conduction to maintain adequate heart rhythm. The lead is designed to be durable and compatible with various pacemaker models.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in patients with arrhythmias that necessitate pacemaker intervention. It is typically implanted in hospital settings during cardiac procedures. The lead is suitable for adult patients who require long-term pacing support.
Indications for Use
The device is indicated for patients who need cardiac pacing due to conditions such as bradycardia or heart block. It is used to help maintain a regular heart rhythm in patients with these conditions.
Practical Considerations
The Model 486-03 lead is available in various lengths to accommodate different patient anatomies. It is compatible with a range of pacemaker devices, and implantation requires careful surgical technique to ensure proper placement and function.
Frequently Asked Questions
What is Model 486-03 Poly Flex Implantable Pacing Lead used for?
It is used for cardiac pacing in patients with arrhythmias requiring a pacemaker.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients needing 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.