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lead body changes to hi perform fast-pass leads
Pacesetter Systems
Summary: The lead body changes to hi perform fast-pass leads by Pacesetter Systems are used in clinical settings for specific indications. The device was cleared by the FDA via the 510k pathway. Key evidence includes 13 studies, though specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway
510K
Number
K861464 ↗
Decision Date
May 19, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared by the FDA through the 510k pathway on May 19, 1986. It is manufactured by Pacesetter Systems and classified as a Class 3 device.
What It Is
The device involves modifications to the lead body to enhance performance in fast-pass leads. It is intended for use in clinical scenarios requiring precise lead placement and performance.
Clinical Applications
Commonly used in scenarios requiring reliable lead performance, such as in cardiac procedures where precise lead placement is critical. It is designed to improve the efficacy of lead-based interventions.
Evidence Summary
The available literature includes 13 studies, though specific details on study types, total sample size, and date range are not provided. The evidence base appears to be diverse, covering various aspects of device performance.
Reported Outcomes
Published studies report limited specific outcomes related to the device. The evidence provided does not detail efficacy findings directly associated with the device's use.
Safety Profile
Reported complications include a lack of specific safety data in the provided evidence. The studies do not detail adverse events directly linked to the device.
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 lead body changes to hi perform fast-pass leads?
Refer to FDA documentation for specific clinical indications.
What outcomes have been reported in clinical studies?
The provided evidence does not specify detailed outcomes related to the device.
What complications have been reported?
The evidence does not provide specific safety data or reported complications for the device.
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.