W L Gore Associates Inc3250 W Kiltie Laneflagstaff Az 86001 Pma Numberp130006 Supplement Numbers094 Date Received12 15 2022 Decision Date12 21 2022 Product Code Pfv 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 Inc3250 W Kiltie Laneflagstaff Az 86001 Pma Numberp130006 Supplement Numbers094 Date Received12 15 2022 Decision Date12 21 2022 Product Code Pfv 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 P130006S094 W.L. GORE & ASSOCIATES,INC3250 W.kiltie Laneflagstaff, AZ 86001 PMA NumberP130006 Supplement NumberS094 Date Received12/15/2022 Decision Date12/21/2022 Product Code PFV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface	2022-12-21