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permanent pacing leads models physique pb and pjb
Oscor
Summary: The Physique PB and PJB are permanent pacing leads used in cardiac pacing. They are typically employed by cardiologists and electrophysiologists to manage arrhythmias in patients requiring long-term pacing solutions.
FDA Clearance Information
Pathway
510K
Number
K024053 ↗
Decision Date
January 31, 2003
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Physique PB and PJB leads by Oscor were cleared through the FDA 510k pathway on January 31, 2003. They are classified as Class III devices under product code DTB.
What It Is
The Physique PB and PJB are permanent pacing leads designed for use in cardiac pacing systems. These leads are implanted in the heart to deliver electrical impulses that regulate heartbeats in patients with arrhythmias. They are made to be durable and flexible, ensuring long-term functionality and patient comfort. The leads connect to a pacemaker, which controls the pacing rate based on the patient's needs.
Clinical Applications
These pacing leads are commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or heart block. Cardiologists and electrophysiologists in hospital settings typically perform these procedures. The leads are suitable for a wide range of patients, including those with chronic heart conditions requiring continuous pacing support.
Indications for Use
The FDA indications for these leads involve their use in patients who need permanent cardiac pacing due to conditions like bradycardia or heart block. They are intended for individuals who require consistent heart rate management to maintain adequate cardiac output.
Practical Considerations
When selecting these leads, clinicians should consider the patient's anatomy and the specific pacing requirements. Compatibility with the chosen pacemaker device is crucial. Proper implantation technique is essential to ensure optimal lead placement and function.
Frequently Asked Questions
What is the Physique PB and PJB used for?
These leads are used for permanent cardiac pacing in patients with arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these leads in hospital settings for cardiac pacing procedures.
What are the FDA-cleared indications?
These leads are indicated for use in patients requiring permanent cardiac pacing due to conditions like 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.