Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

April 17, 2010

Last updated

August 9, 2024

Description

This document is a guidance for industry and FDA staff on non-clinical engineering tests and labeling for intravascular stents and delivery systems.

Organization

Country / Region

United States

License

Other (Public Domain)

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