đź“‹ FDA Reference
myopore r sutureless myocardial pacing lead
Great Batch Medical
Summary: The Myopore R Sutureless Myocardial Pacing Lead is a medical device used for pacing the heart without sutures. It is typically used by cardiologists and cardiac surgeons in procedures requiring myocardial pacing.
FDA Clearance Information
Pathway
PMA
Number
P130012 ↗
Decision Date
April 19, 2024
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Myopore R Sutureless Myocardial Pacing Lead was cleared by the FDA through the PMA pathway on April 19, 2024. Manufactured by Great Batch Medical, it is classified as a Class III device.
What It Is
The Myopore R Sutureless Myocardial Pacing Lead is a specialized device designed to provide temporary pacing to the heart without the need for sutures. It works by attaching directly to the myocardium, offering a less invasive option for myocardial pacing. This device is particularly useful in situations where traditional suturing is not feasible or desirable.
Clinical Applications
This device is commonly used in cardiac surgery and cardiology, particularly in settings where temporary pacing is required, such as during or after cardiac surgery. It is suitable for use in adult patients who require temporary pacing support. The device is typically used in hospital settings, particularly in operating rooms and intensive care units.
Indications for Use
The FDA indication for this device involves a change in the cleaning method for the Myopore Sutureless Myocardial Pacing Lead. Clinically, this means the device is intended for use in patients who need temporary myocardial pacing, without the complications associated with sutures.
Practical Considerations
The Myopore R lead is designed for ease of use, with compatibility for various pacing systems. Clinicians should be aware of the specific attachment techniques required for sutureless application, and ensure proper device handling to maintain sterility and functionality.
Frequently Asked Questions
What is the Myopore R Sutureless Myocardial Pacing Lead used for?
It is used for providing temporary pacing to the heart without the need for sutures.
What specialties typically use this device?
Cardiologists and cardiac surgeons typically use this device in surgical and intensive care settings.
What are the FDA-cleared indications?
The device is indicated for use in temporary myocardial pacing, with a focus on a new cleaning method for the lead.
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.