đź“‹ FDA Reference
Modified Oscor Py Pacing Leads Modification
Oscor Medical
Summary: The modified Oscor Py pacing leads are used for cardiac pacing in patients requiring temporary or permanent pacing. They are primarily used by cardiologists and cardiac surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K913158 ↗
Decision Date ?
September 23, 1991
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The modified Oscor Py pacing leads were cleared through the FDA 510(k) pathway on September 23, 1991. Manufactured by Oscor Medical, this Class 3 device is intended for cardiac pacing.
What It Is
The modified Oscor Py pacing leads are specialized medical devices used to deliver electrical impulses to the heart to maintain an adequate heart rate. They consist of insulated wires that connect the heart to an external pacemaker or an implantable device. These leads are crucial in managing arrhythmias and ensuring proper cardiac function in patients with heart rhythm disorders.
FDA-Cleared Indications
- Cardiac pacing in patients who require electrical stimulation to maintain an adequate heart rate.
- Use with temporary external pacing systems when short-term cardiac pacing is needed.
- Use with implantable pacemaker systems when permanent cardiac pacing is required.
Clinical Applications
- Temporary cardiac pacing during hospital-based treatment of bradycardia or heart block.
- Connection of a cardiac lead to an external pacemaker during an acute pacing requirement.
- Permanent cardiac pacing when the lead is used with a compatible implanted pacemaker system.
- Cardiac pacing procedures performed by cardiologists or cardiac surgeons in an operating room or cardiac procedure area.
Practical Considerations
- The lead length and configuration must match the patient’s anatomy, intended lead position and pacing system.
- Compatibility with the external or implanted pacemaker, connectors and other system components must be confirmed before use.
- Lead placement requires appropriate cardiac imaging, monitoring and pacing assessment by trained clinicians.
- The available record does not establish MRI safety; MRI use should be avoided unless the complete pacing system is specifically labeled as MR safe or MR conditional.
- Potential complications include lead displacement, failure to capture, abnormal heart rhythms, infection, bleeding and injury to cardiac or vascular structures.
Frequently Asked Questions
What is modified Oscor Py pacing leads used for?
They are used for cardiac pacing in patients with arrhythmias or heart block to maintain adequate heart rate.
What specialties typically use this device?
Cardiologists and cardiac surgeons typically use these leads in hospital settings.
What are the FDA-cleared indications?
They are indicated for patients requiring temporary or 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.