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pacesetter sys fast pass endocardial lead 856 inli
Pacesetter Systems
Summary: The Pacesetter Sys Fast Pass Endocardial Lead 856 Inli is a cardiac lead used in pacemaker systems to deliver electrical impulses to the heart. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K853914 ↗
Decision Date
December 3, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Pacesetter Sys Fast Pass Endocardial Lead 856 Inli was cleared via the FDA 510(k) pathway on December 3, 1985. It is manufactured by Pacesetter Systems and classified as a Class III device.
What It Is
The Pacesetter Sys Fast Pass Endocardial Lead 856 Inli is a specialized cardiac lead designed for use in pacemaker systems. It is implanted endocardially, meaning it is placed inside the heart's chambers. The lead facilitates the transmission of electrical impulses from the pacemaker to the heart muscle, ensuring proper cardiac rhythm management. This device is crucial for patients with arrhythmias or heart block who require consistent pacing support.
Clinical Applications
This endocardial lead is commonly used in the implantation of pacemaker systems, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists typically perform these procedures in hospital settings, often in specialized cardiac catheterization labs. The device is suitable for adult patients requiring long-term pacing therapy and is integral to maintaining adequate heart function in these populations.
Indications for Use
The FDA indications suggest this device is intended for patients who need cardiac pacing due to conditions like bradycardia or heart block. It is used to ensure the heart maintains a regular and adequate rhythm.
Practical Considerations
When considering this lead, clinicians should be aware of its compatibility with various pacemaker generators. Proper sizing and placement technique are critical for optimal performance and patient safety. Familiarity with endocardial lead implantation procedures is essential for successful outcomes.
Frequently Asked Questions
What is the Pacesetter Sys Fast Pass Endocardial Lead 856 Inli used for?
It is used for cardiac pacing in patients with arrhythmias or heart block, ensuring the heart maintains a proper rhythm.
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 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.