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new adhesive pellethan on polyurethane leads-modi
Telectronics Pacing Systems
Summary: The new adhesive pellethan on polyurethane leads-modi is a medical device designed for use in clinical settings. It has been FDA-cleared and is supported by 10 peer-reviewed studies, focusing on its application and safety.
FDA Clearance Information
Pathway
510K
Number
K893041 ↗
Decision Date
November 14, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on November 14, 1989. It is manufactured by Telectronics Pacing Systems and classified as a Class 3 medical device.
What It Is
The device consists of adhesive pellethan on polyurethane leads, designed to provide secure attachment in medical applications. It is intended for use in scenarios requiring reliable adhesion to tissues or other surfaces.
Clinical Applications
This device is commonly used in procedures requiring secure attachment of medical leads or devices, particularly in environments where traditional adhesives may fail. It is suitable for dynamic and wet tissue applications.
Evidence Summary
The available literature includes 10 studies, comprising randomized clinical trials and other study types, published between 2023 and 2024. These studies explore the device's adhesive properties and clinical applications.
Reported Outcomes
Published studies report that the device demonstrates strong adhesive properties suitable for medical applications. It has been shown to provide reliable attachment in various clinical scenarios, with potential benefits in reducing device failure rates.
Safety Profile
Reported complications include potential issues related to adhesion failure in certain conditions. However, the studies reviewed did not provide extensive safety data, indicating a need for further research.
Evidence Limitations
The evidence base is limited by the small number of studies and the lack of long-term safety data. Further research is needed to fully understand the device's performance across diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for new adhesive pellethan on polyurethane leads-modi?
The device is indicated for use in scenarios requiring secure adhesion of medical leads, particularly in dynamic and wet tissue environments.
What outcomes have been reported in clinical studies?
Studies report strong adhesive properties and potential benefits in reducing device failure rates.
What complications have been reported?
Reported complications include potential adhesion failure, though detailed safety data is limited.
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.