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permanent pacing lead model py2
Oscor
Summary: The Permanent Pacing Lead Model PY2 by Oscor is a cardiac device used to provide permanent pacing for patients with heart rhythm disorders. It is primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K041809 ↗
Decision Date
August 6, 2004
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Permanent Pacing Lead Model PY2 received FDA clearance through the 510k pathway on August 6, 2004. Manufactured by Oscor, it is classified as a Class III device under product code DTB.
What It Is
The Permanent Pacing Lead Model PY2 is a medical device designed to deliver electrical impulses to the heart, ensuring proper heart rhythm in patients with bradycardia or other rhythm disorders. It is a flexible, insulated wire that connects the heart to an implanted pacemaker. The lead senses cardiac electrical activity and delivers pacing pulses when needed.
Clinical Applications
This device is commonly used in procedures involving the implantation of pacemakers, particularly in patients with symptomatic bradycardia or heart block. It is typically utilized in hospital settings by cardiologists and electrophysiologists. The device is suitable for adult and pediatric patients requiring long-term pacing support.
Indications for Use
The Permanent Pacing Lead Model PY2 is indicated for patients who require permanent pacing due to conditions like bradycardia or heart block. It is suitable for individuals who have difficulty maintaining an adequate heart rate on their own.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker systems. Proper placement and secure fixation are crucial to ensure effective pacing and minimize complications.
Frequently Asked Questions
What is Permanent Pacing Lead Model PY2 used for?
It is used to provide permanent cardiac pacing for patients with heart rhythm disorders like bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for patients requiring permanent pacing due to conditions such as 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.