📋 FDA Reference
Resubmission of Model 030-437 Implant Electrode
Telectronics
Summary: The Model 030-437 Implant Electrode by Telectronics is an FDA-cleared medical device used in the management of cardiac conditions. It is typically used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K870610 ↗
Decision Date ?
March 20, 1987
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Model 030-437 Implant Electrode was cleared through the FDA 510(k) pathway on March 20, 1987. It is manufactured by Telectronics and classified as a Class III device.
What It Is
The Model 030-437 Implant Electrode is a medical device designed for implantation in patients requiring cardiac rhythm management. It functions as part of a pacemaker or defibrillator system, delivering electrical impulses to the heart muscle to maintain an appropriate heart rate and rhythm. This device is crucial in managing arrhythmias and preventing sudden cardiac arrest.
FDA-Cleared Indications
- Use as an implant electrode in a cardiac pacing system for patients who require electrical stimulation to manage cardiac rhythm abnormalities.
- Use in patients with bradycardia or heart block when cardiac pacing is clinically indicated.
Clinical Applications
- Implantation as part of a permanent pacemaker system.
- Delivery of electrical impulses to the heart muscle to support an appropriate heart rate and rhythm.
- Treatment of symptomatic slow heart rhythms associated with bradycardia.
- Pacing support for selected patients with heart block.
Practical Considerations
- Compatibility must be confirmed with the intended pacemaker, pulse generator, or other cardiac rhythm-management equipment before implantation.
- The record identifies the device as an implant electrode but does not provide current detailed specifications for lead length, diameter, connector type, fixation mechanism, or pacing location; clinicians should consult the original labeling and device documentation.
- Implantation requires appropriate sterile technique, imaging or physiologic guidance as applicable, and testing of lead position and electrical performance.
- MRI safety cannot be determined from this historical FDA record. Do not assume the electrode is MRI-conditional; verify the complete implanted system and manufacturer-specific MRI labeling.
- Potential contraindications, warnings, and handling requirements should be checked in the original labeling and evaluated against the patient's anatomy, infection risk, venous access, and cardiac condition.
Frequently Asked Questions
What is the Model 030-437 Implant Electrode used for?
It is used for cardiac rhythm management in patients with arrhythmias, functioning as part of a pacemaker or defibrillator system.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in the management of cardiac arrhythmias.
What are the FDA-cleared indications?
The device is indicated for patients with cardiac arrhythmias requiring electrical stimulation to maintain a regular heartbeat.
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.