W L Gore Associates Inc 3450 Kiltie Lanep O Box 2400flagstaff Az 86003 2400 Pma Numberp040043 Supplement Numbers130 Date Received01 20 2022 Decision Date02 22 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 Kiltie Lanep O Box 2400flagstaff Az 86003 2400 Pma Numberp040043 Supplement Numbers130 Date Received01 20 2022 Decision Date02 22 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 Filings

Device Company	Device	Date
PMA P040043S130 W. L. GORE & ASSOCIATES, INC.3450 Kiltie Lanep.o. Box 2400flagstaff, AZ 86003-2400 PMA NumberP040043 Supplement NumberS130 Date Received01/20/2022 Decision Date02/22/2022 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 Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System	2022-02-22