W L Gore Associates Inc3250 W Kiltie Laneflagstaff Az 86001 Pma Numberp130006 Supplement Numbers093 Date Received08 08 2022 Decision Date09 01 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 Numbers093 Date Received08 08 2022 Decision Date09 01 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 Registration(s)

FDA Filings

Device
Company
DeviceDate
W.L. GORE & ASSOCIATES,INC3250 W.kiltie Laneflagstaff, AZ 86001 PMA NumberP130006 Supplement NumberS093 Date Received08/08/2022 Decision Date09/01/2022 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 with Heparin Bioactive Surface2022-09-01

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