📋 FDA Reference
Permanent Pacing Leads Models Physique Pb and Pjb
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as permanent pacing leads in a cardiac pacing system.
- Use in patients who require permanent cardiac pacing, including patients with bradycardia or heart block, when clinically indicated.
Clinical Applications
- Placement during implantation of a permanent pacemaker.
- Delivery of pacing impulses to the heart in patients requiring long-term rate support.
- Use in cardiac pacing systems selected and implanted by qualified cardiology or electrophysiology clinicians.
Practical Considerations
- The lead must be compatible with the selected pacemaker generator and the intended pacing configuration.
- Lead selection and placement should account for cardiac anatomy, the target chamber, pacing requirements, and venous access.
- Implantation requires imaging and electrical testing to confirm appropriate position and lead function.
- MRI compatibility should not be assumed; verify the specific lead, generator, and complete implanted system in the current labeling before MRI.
- Potential complications include vascular or cardiac perforation, bleeding, infection, lead displacement, lead malfunction, and the need for revision or extraction.
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.