W L Gore Associates Inc 3450 Kiltie Lanep O Box 2400flagstaff Az 86003 2400 Pma Numberp040043 Supplement Numbers132 Date Received12 15 2022 Decision Date01 12 2023 Product Code Mih Advisory Committee Cardiovascular Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 Numbers132 Date Received12 15 2022 Decision Date01 12 2023 Product Code Mih Advisory Committee Cardiovascular Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 P040043S132 W. L. GORE & ASSOCIATES, INC.3450 Kiltie Lanep.o. Box 2400flagstaff, AZ 86003-2400 PMA NumberP040043 Supplement NumberS132 Date Received12/15/2022 Decision Date01/12/2023 Product Code MIH  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	GORE TAG Conformable Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System	2023-01-12