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maxim pfs model 033-301
St. Jude Medical, Cardiac Rhythm Management Divisi
Summary: The Maxim PFS Model 033-301 is a pacing lead designed for chronic pacing and sensing of the ventricle. It is used by cardiologists in conjunction with a compatible pulse generator to manage heart rhythm disorders.
FDA Clearance Information
Pathway PMA
Number P920011 ↗
Decision Date November 7, 1996
Product Code DTB
Device Class Class 3
Evidence 0 studies
The Maxim PFS Model 033-301 received FDA clearance through the PMA pathway on November 7, 1996. It is manufactured by St. Jude Medical and classified as a Class III device.
What It Is
The Maxim PFS Model 033-301 is a cardiac pacing lead used in conjunction with a pulse generator to deliver electrical impulses to the heart. This device helps maintain an adequate heart rate by providing pacing support to the ventricles. It is designed for long-term implantation and is typically used in patients with bradycardia or other rhythm disorders requiring ventricular pacing.
Clinical Applications
This device is primarily used in cardiology, particularly in electrophysiology and cardiac rhythm management. It is commonly implanted in hospital settings during procedures to address conditions like heart block or sick sinus syndrome. The typical patient population includes those with symptomatic bradycardia or other conditions that necessitate ventricular pacing support.
Indications for Use
The Maxim PFS Model 033-301 is indicated for patients who require chronic ventricular pacing and sensing. It is suitable for individuals with conditions such as heart block or bradycardia, where maintaining a consistent heart rhythm is crucial.
Practical Considerations
When considering this device, ensure compatibility with the chosen pulse generator. The lead is designed for chronic use, so attention to implantation technique and lead positioning is critical for optimal performance. Clinicians should be familiar with the sizing and handling of the lead during implantation procedures.
Frequently Asked Questions
What is the Maxim PFS Model 033-301 used for?
It is used for chronic pacing and sensing of the ventricle in patients with heart rhythm disorders.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac rhythm management, use this device.
What are the FDA-cleared indications?
It is indicated for chronic pacing and sensing of the ventricle in patients needing ventricular pacing support.
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.