đź“Š Evidence-Based Reference
biplr im en pac leads 430-07 432-03 436-02 07 438-05 07
Intermedics
Summary: The biplr im en pac leads by Intermedics is a Class 3 medical device cleared by the FDA for use in specific clinical scenarios. Key evidence includes studies on its application and safety.
FDA Clearance Information
Pathway
510K
Number
K962174 ↗
Decision Date
August 21, 1996
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510k pathway on August 21, 1996. Manufactured by Intermedics, it is classified as a Class 3 device.
What It Is
The biplr im en pac leads are specialized medical devices used in cardiac procedures. They are designed to facilitate electrical conduction in pacemaker systems, ensuring proper cardiac rhythm management.
Clinical Applications
These leads are commonly used in patients requiring pacemaker implantation due to arrhythmias or other cardiac conduction disorders. They are integral in maintaining effective heart rate control.
Evidence Summary
The available literature includes 5 studies, with types ranging from retrospective to prospective analyses. The studies span from 2023 to 2025, providing insights into clinical outcomes and safety.
Reported Outcomes
Published studies report varied clinical outcomes, focusing on the efficacy of the device in maintaining cardiac rhythm. However, specific efficacy data from the provided evidence is not detailed.
Safety Profile
Reported complications include general device-related issues, but specific safety data from the provided evidence is not detailed.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the device. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for biplr im en pac leads?
Clinical indications are detailed in the FDA documentation, primarily involving cardiac rhythm management.
What outcomes have been reported in clinical studies?
Specific findings from the provided evidence are not detailed, but studies generally focus on efficacy in cardiac rhythm management.
What complications have been reported?
Safety data from the provided evidence is not detailed, but general device-related complications are noted.
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.