W L Gore Associates Inc3450 West Kiltie Ln P O Box 500flagstaff Az 86002 0500 Pma Numberp040037 Supplement Numbers150 Date Received01 20 2022 Decision Date02 22 2022 Product Code Nip 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 Inc3450 West Kiltie Ln P O Box 500flagstaff Az 86002 0500 Pma Numberp040037 Supplement Numbers150 Date Received01 20 2022 Decision Date02 22 2022 Product Code Nip 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 P040037S150 W.L. GORE & ASSOCIATES,INC3450 West Kiltie Ln.p.o. Box 500flagstaff, AZ 86002-0500 PMA NumberP040037 Supplement NumberS150 Date Received01/20/2022 Decision Date02/22/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface	2022-02-22