W L Gore Associates Inc 3450 West Kiltie Laneflagstaff Az 86005 Pma Numberp210032 Supplement Numbers002 Date Received06 22 2022 Decision Date07 21 2022 Product Code Mih Advisory Committee Cardiovascular Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for W L Gore Associates Inc 3450 West Kiltie Laneflagstaff Az 86005 Pma Numberp210032 Supplement Numbers002 Date Received06 22 2022 Decision Date07 21 2022 Product Code Mih Advisory Committee Cardiovascular Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS002 Date Received06/22/2022 Decision Date07/21/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
GORE® TAG® Thoracic Branch Endoprosthesis2022-07-21

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