đź“‹ FDA Reference
model mz pacemaker lead-various
Oscor
Summary: The Model MZ Pacemaker Lead-Various by Oscor is a cardiac device used to connect a pacemaker to the heart muscle, facilitating electrical impulse delivery. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K823893 ↗
Decision Date
April 30, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model MZ Pacemaker Lead-Various was cleared through the FDA 510k pathway on April 30, 1983. It is manufactured by Oscor and classified as a Class III device.
What It Is
The Model MZ Pacemaker Lead-Various is a medical device designed to connect a pacemaker to the heart muscle, ensuring effective delivery of electrical impulses to regulate heartbeats. Pacemaker leads are critical components in cardiac pacing systems, providing the electrical interface between the pacemaker and the heart. These leads are typically inserted transvenously and positioned in the heart chambers, often in the right atrium or ventricle.
Clinical Applications
This device is commonly used in clinical settings where patients require cardiac pacing, such as in cases of bradycardia or heart block. Cardiologists, particularly those specializing in electrophysiology, utilize these leads during pacemaker implantation procedures. The device is suitable for use in both adult and pediatric populations, depending on the specific pacing needs and anatomical considerations.
Indications for Use
The FDA indications for this pacemaker lead involve its use in patients who require electrical pacing of the heart due to conditions like arrhythmias or heart block. It is intended for use in conjunction with a pacemaker to maintain adequate heart rate and rhythm.
Practical Considerations
When selecting a pacemaker lead, considerations include the lead's length, diameter, and compatibility with the pacemaker device. Proper technique during insertion is crucial to ensure optimal positioning and function. Clinicians should be aware of potential complications such as lead dislodgement or fracture.
Related Literature
The linked study focuses on the use of covered stents for correcting sinus venosus atrial septal defects (SVASD), an alternative to traditional surgical repair. It highlights the increasing adoption of this technique since 2016, despite not being recognized by regulatory authorities. The study suggests that covered stent correction is becoming a standard care option in certain centers. However, it notes limitations in broader acceptance and regulatory approval.
Frequently Asked Questions
What is Model MZ Pacemaker Lead-Various used for?
It is used to connect a pacemaker to the heart muscle, facilitating electrical impulse delivery for cardiac pacing.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology, use this device during pacemaker implantation procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring electrical pacing of the heart due to conditions like arrhythmias 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.