đź“‹ FDA Reference
Maxim Pfs Model 033-301
St. Jude Medical, Cardiac Rhythm Management Divisi
Summary: The Maxim PFS Model 033-301 is a pacing lead designed for chronic pacing and sensing of the ventricle. It is used by cardiologists in conjunction with a compatible pulse generator to manage heart rhythm disorders.
FDA Clearance Information
Pathway ?
PMA
Number ?
P920011 ↗
Decision Date ?
November 7, 1996
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Maxim PFS Model 033-301 received FDA clearance through the PMA pathway on November 7, 1996. It is manufactured by St. Jude Medical and classified as a Class III device.
What It Is
The Maxim PFS Model 033-301 is a cardiac pacing lead used in conjunction with a pulse generator to deliver electrical impulses to the heart. This device helps maintain an adequate heart rate by providing pacing support to the ventricles. It is designed for long-term implantation and is typically used in patients with bradycardia or other rhythm disorders requiring ventricular pacing.
FDA-Cleared Indications
- Chronic pacing of the ventricle when used with a compatible pulse generator.
- Chronic sensing of the ventricle when used with a compatible pulse generator.
Clinical Applications
- Long-term ventricular pacing as part of an implanted pacemaker system.
- Ventricular sensing by a compatible cardiac pulse generator.
- Use during implantation of a compatible pacemaker system for patients requiring chronic ventricular pacing support.
Practical Considerations
- The lead must be confirmed compatible with the selected pulse generator before implantation.
- Implantation requires appropriate positioning of the lead in the ventricle and testing of pacing and sensing function.
- MRI safety cannot be determined from this FDA record alone; the complete implanted system must be evaluated against current manufacturer MRI labeling.
- The device is intended for chronic implantation, so lead integrity, fixation, electrical performance and follow-up should be monitored over time.
- Contraindications and precautions should be reviewed in the current device labeling and considered alongside the patient's anatomy, rhythm disorder and overall clinical condition.
Frequently Asked Questions
What is the Maxim PFS Model 033-301 used for?
It is used for chronic pacing and sensing of the ventricle in patients with heart rhythm disorders.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac rhythm management, use this device.
What are the FDA-cleared indications?
It is indicated for chronic pacing and sensing of the ventricle in patients needing ventricular pacing support.
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.