W L Gore Associates Inc 3250 West Kiltie Laneflagstaff Az 86005 Pma Numberp160021 Supplement Numbers036 Date Received12 15 2022 Decision Date12 21 2022 Product Code Prl 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 Inc 3250 West Kiltie Laneflagstaff Az 86005 Pma Numberp160021 Supplement Numbers036 Date Received12 15 2022 Decision Date12 21 2022 Product Code Prl 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 P160021S036 W. L. Gore & Associates, Inc.3250 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP160021 Supplement NumberS036 Date Received12/15/2022 Decision Date12/21/2022 Product Code PRL  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis	2022-12-21