W L Gore Associates Inc32360 N North Valley Parkwayphoenix Az 85085 Pma Numberp020004 Supplement Numbers189 Date Received02 01 2022 Decision Date07 28 2022 Product Code Mih Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee 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 Inc32360 N North Valley Parkwayphoenix Az 85085 Pma Numberp020004 Supplement Numbers189 Date Received02 01 2022 Decision Date07 28 2022 Product Code Mih Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee 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 P020004S189 W.L. GORE & ASSOCIATES,INC32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP020004 Supplement NumberS189 Date Received02/01/2022 Decision Date07/28/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No	GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)	2022-07-28