đź“‹ FDA Reference
Model Py U Unipolar Bipolar Pacing Lead
Oscor Medical
Summary: The Model PY U is a unipolar/bipolar pacing lead used in cardiac pacing procedures. It is utilized by cardiologists and electrophysiologists to maintain heart rhythm in patients with arrhythmias.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K870034 ↗
Decision Date ?
March 3, 1987
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Model PY U Pacing Lead by Oscor Medical was cleared through the FDA 510(k) pathway on March 3, 1987. It is a Class III medical device under product code DTB.
What It Is
The Model PY U Pacing Lead is a specialized lead designed for cardiac pacing, available in both unipolar and bipolar configurations. It is implanted into the heart to deliver electrical impulses that regulate heartbeats in patients with arrhythmias. The lead connects to a pacemaker, which controls the timing and strength of the impulses.
FDA-Cleared Indications
- Cardiac pacing in patients with arrhythmias requiring electrical stimulation.
- Pacing support for patients with clinically significant slow heart rates or other rhythm disturbances, as specified by the applicable labeling.
Clinical Applications
- Implantation as part of a permanent pacemaker system for patients requiring cardiac pacing.
- Delivery of pacing impulses from a compatible pacemaker to the heart.
- Use in unipolar or bipolar pacing configurations, according to the pacemaker system and clinical requirements.
- Use during cardiac pacing procedures performed by qualified cardiology or electrophysiology clinicians.
Practical Considerations
- The lead is available in unipolar and bipolar configurations; clinicians should confirm compatibility with the intended pacemaker generator.
- Different lead lengths may be available to accommodate patient anatomy and the planned implantation route.
- Correct positioning, fixation, electrical testing and connection are required to achieve reliable pacing performance.
- The provided FDA record does not establish MRI safety; MRI-conditional status should be confirmed from current device labeling before scanning.
- Contraindications, warnings, connector requirements and handling instructions should be checked in the manufacturer’s labeling and used with the selected pacemaker system.
Frequently Asked Questions
What is the Model PY U Pacing Lead used for?
It is used for cardiac pacing to regulate heart rhythms in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to arrhythmias, such as bradycardia.
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.