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medtronic unipolar poly pac lead-barr coat coils
Medtronic Vascular
Summary: The Medtronic Unipolar Poly Pac Lead-Barr Coat Coils are cardiac pacing leads used in cardiac rhythm management. They are primarily utilized by cardiologists and electrophysiologists for patients requiring pacemaker implantation.
FDA Clearance Information
Pathway
510K
Number
K913288 ↗
Decision Date
October 17, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on October 17, 1991, by Medtronic Vascular. It is classified as a Class III medical device, indicating a higher level of regulatory control due to potential risk.
What It Is
The Medtronic Unipolar Poly Pac Lead-Barr Coat Coils are specialized leads used in conjunction with pacemakers for cardiac rhythm management. These leads are designed to conduct electrical impulses from the pacemaker to the heart muscle, ensuring proper heart rhythm. The unipolar design involves a single electrode at the tip of the lead, which is in contact with the heart tissue.
Clinical Applications
These leads are commonly used in procedures involving pacemaker implantation, particularly in patients with bradycardia or other rhythm disorders. Cardiologists and electrophysiologists typically perform these procedures in hospital settings. The device is suitable for adult and pediatric patients who require long-term cardiac pacing.
Indications for Use
The FDA indications suggest that this device is intended for patients who need cardiac pacing due to conditions like bradycardia. It is suitable for use in individuals who require reliable electrical conduction to maintain heart rhythm.
Practical Considerations
Clinicians should consider the lead's compatibility with the chosen pacemaker system. Proper sizing and placement technique are crucial for optimal performance, and training in lead implantation is recommended for best outcomes.
Frequently Asked Questions
What is Medtronic Unipolar Poly Pac Lead-Barr Coat Coils used for?
This device is used for cardiac pacing in patients with rhythm disorders such as bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during pacemaker implantation procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing to manage heart rhythm disorders.
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.