Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

Name: Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: 510k,fda,guidances,industry,notification,pre-market,pre-market-notification,stents,submissions

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

July 26, 2019

Last updated

August 9, 2024

Description

This document is a guidance for industry and FDA staff on premarket notification submissions for metal expandable biliary stents.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

Updated on August 9, 2024

pdf (369.7KB)

URL: https://www.fda.gov/media/72693/download
Permalink: https://data.openrid.co/en/datasets/r/2972bb55-3e54-407c-9b3b-33ea6314079d
MIME Type: application/pdf

Created on: July 26, 2019
Modified on: August 9, 2024

Size: 369.7KB

Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

Information

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Regulated products

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Published

Last updated

Description

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Country / Region

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