W L Gore Associates Inc32360 N North Valley Parkwayphoenix Az 85085 Pma Numberp020004 Supplement Numbers191 Date Received08 12 2022 Decision Date09 13 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 Inc32360 N North Valley Parkwayphoenix Az 85085 Pma Numberp020004 Supplement Numbers191 Date Received08 12 2022 Decision Date09 13 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 P020004S191 W.L. GORE & ASSOCIATES,INC32360 N. North Valley Parkwayphoenix, AZ 85085 PMA NumberP020004 Supplement NumberS191 Date Received08/12/2022 Decision Date09/13/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)	2022-09-13